A Study of Different Combination Regimens Including JNJ-7... | NCT03982186 | Trialant
NCT03982186
Sponsor
Janssen Sciences Ireland UC
Status
Completed
Last Update Posted
Feb 4, 2025Actual
Enrollment
471Actual
Phase
Phase 2
Conditions
Hepatitis B, Chronic
Interventions
JNJ-73763989
Placebo for JNJ-73763989
JNJ-56136379
Placebo for JNJ-56136379
Nucleos(t)ide Analog (NA)
Countries
United States
Belgium
Brazil
Canada
China
Czechia
France
Germany
Hong Kong
Italy
Japan
Malaysia
Poland
Russia
South Korea
Spain
Thailand
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03982186
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108608
Secondary IDs
ID
Type
Description
Link
2019-000622-22
EudraCT Number
73763989HPB2001
Other Identifier
Janssen Sciences Ireland UC
Brief Title
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Official Title
A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Acronym
REEF-1
Organization
Janssen Sciences Ireland UCINDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1, 2019Actual
Primary Completion Date
Mar 29, 2021Actual
Completion Date
Apr 26, 2022Actual
First Submitted Date
Jun 10, 2019
First Submission Date that Met QC Criteria
Jun 10, 2019
First Posted Date
Jun 11, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Mar 27, 2024
Results First Submitted that Met QC Criteria
Jul 5, 2024
Results First Posted Date
Jul 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 28, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 10, 2024Actual
Last Update Submitted Date
Jan 31, 2025
Last Update Posted Date
Feb 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Sciences Ireland UCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.
Detailed Description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent [%]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate efficacy as measured by proportion of participants who completed 48-week study intervention and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4 weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The duration of individual study participation will be between 100 and 150 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HBsAg seroclearance), and pharmacokinetics will be assessed throughout the study.
Conditions Module
Conditions
Hepatitis B, Chronic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
471Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA
Experimental
Participants will receive medium dose of JNJ-73763989 along with JNJ-56136379 and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) up to 48 weeks.
Drug: JNJ-73763989
Drug: JNJ-56136379
Drug: Nucleos(t)ide Analog (NA)
Arm 2: JNJ-73763989 (high dose) + Placebo + NA
Experimental
Participants will receive high dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: JNJ-73763989
Drug: Placebo for JNJ-56136379
Drug: Nucleos(t)ide Analog (NA)
Arm 3: JNJ-73763989 (medium dose) + Placebo + NA
Experimental
Participants will receive medium dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: JNJ-73763989
Drug: Placebo for JNJ-56136379
Drug: Nucleos(t)ide Analog (NA)
Arm 4: JNJ-73763989 (low dose) + Placebo + NA
Experimental
Participants will receive low dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: JNJ-73763989
Drug: Placebo for JNJ-56136379
Drug: Nucleos(t)ide Analog (NA)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
JNJ-73763989
Drug
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.
Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48
Percentage of participants meeting the NA treatment completion criteria at Week 48 were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (<) 3*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) <10 international units per milliliter (IU/mL). Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
Week 48
Secondary Outcomes
Measure
Description
Time Frame
Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening
Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) at screening
Exclusion Criteria:
Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
Evidence of liver disease of non-HBV etiology
Signs of hepatocellular carcinoma (HCC)
Significant laboratory abnormalities as defined in the protocol at screening
Participants with a history of malignancy within 5 years before screening
Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
History of or current clinically significant skin disease or drug rash
Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 and JNJ 6379 or their excipients or excipients of the placebo content
Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information
Participants who have taken any therapies disallowed per protocol
Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
Male participants who plan to father a child while enrolled
Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)
Verbinnen T, Lathouwers E, Jezorwski J, Biermer M, Augustyns I, Grant C, Agarwal K, Yuen MF, De Meyer S, Lenz O. Viral sequence analysis of chronic hepatitis B patients treated with the siRNA JNJ-73763989 in phase II clinical trials. JHEP Rep. 2025 Oct 9;7(12):101618. doi: 10.1016/j.jhepr.2025.101618. eCollection 2025 Dec.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 24, 2021
Mar 27, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Arm 5: Placebo + JNJ-56136379 + NA
Experimental
Participants will receive placebo for JNJ-73763989 and a fixed dose of JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: Placebo for JNJ-73763989
Drug: JNJ-56136379
Drug: Nucleos(t)ide Analog (NA)
Arm 6 (Control): Placebo + Placebo + NA
Placebo Comparator
Participants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: Placebo for JNJ-73763989
Drug: Placebo for JNJ-56136379
Drug: Nucleos(t)ide Analog (NA)
Arm 2: JNJ-73763989 (high dose) + Placebo + NA
Arm 3: JNJ-73763989 (medium dose) + Placebo + NA
Arm 4: JNJ-73763989 (low dose) + Placebo + NA
Placebo for JNJ-73763989
Drug
Placebo for JNJ-73763989 will be administered as subcutaneous injection.
Arm 5: Placebo + JNJ-56136379 + NA
Arm 6 (Control): Placebo + Placebo + NA
JNJ-56136379
Drug
JNJ-56136379 tablets will be administered orally.
Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA
Arm 5: Placebo + JNJ-56136379 + NA
Placebo for JNJ-56136379
Drug
Placebo for JNJ-56136379 tablets will be administered orally.
Arm 2: JNJ-73763989 (high dose) + Placebo + NA
Arm 3: JNJ-73763989 (medium dose) + Placebo + NA
Arm 4: JNJ-73763989 (low dose) + Placebo + NA
Arm 6 (Control): Placebo + Placebo + NA
Nucleos(t)ide Analog (NA)
Drug
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA
Arm 2: JNJ-73763989 (high dose) + Placebo + NA
Arm 3: JNJ-73763989 (medium dose) + Placebo + NA
Arm 4: JNJ-73763989 (low dose) + Placebo + NA
Arm 5: Placebo + JNJ-56136379 + NA
Arm 6 (Control): Placebo + Placebo + NA
Baseline up to Week 48
Follow-up Phase 1: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
From Week 48 up to Week 96
Follow-up Phase 2: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
From Week 48 up to Week 96
Follow-up Phase 3: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
From Week 48 up to Week 96
Extended Follow-up Phase: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Extended Follow up Week 1 to extended follow up Week 48
Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Baseline up to Week 48
Follow-up Phase 1: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
From Week 48 up to Week 96
Follow-up Phase 2: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
From Week 48 up to Week 96
Follow-up Phase 3: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
From Week 48 up to Week 96
Extended Follow-up Phase: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Extended Follow up Week 1 to extended follow up Week 48
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology)
Percentage of participants with abnormalities in clinical laboratory tests (hematology: Abnormally low [AL] and Abnormally high [AH] basophils, eosinophils, erthrocytes mean corpuscular hemoglobin concentration, erthrocytes mean corpuscular heamoglobin, erthrocytes mean corpuscular volume, erthrocytes, hematocrit, lymphocytes atypical, metamyelocytes, monocytes, myelocytes, neutrophils, segmented, reticulocytes) were reported. Abnormality was determined at the investigator's discretion. Here, M.C: Mean corpuscular. Participants with abnormally low or high values were reported.
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry)
Percentage of participants with abnormalities in clinical laboratory tests (Chemistry: abnormally high and serum alpha fetoprotein, serum chloride, Serum gamma glutamyl tranferase [GGT], Serum high density cholesterol [HDL] Cholesterol, Indirect Bilirubin, Lactate Dehydrogenase, Serum Protein, Urea Nitrogen) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis)
Percentage of participants with abnormalities in clinical laboratory tests(Urinalysis: abnormally high and low urine granular casts, urine hyaline casts, Urine Leukocytes,Urine Specific Gravity,Urine Squamous Epithelial cell, Urine T.E Cells, Urine Transitinoal erythrocyte count [E.C],Urine Tubular erthrocyte count ) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Percentage of Participants With Abnormalities in Electrocardiogram (ECG)
Percentage of participants with abnormalities in ECG parameters (heart rate, PR interval, QRS duration, and QTcF interval) were reported. Abnormality criteria: Heart rate abnormally low (AL): <45 beats per minute (bpm); PR interval AH:>220 msec; QRS duration AH:>120 msec; QTcF borderline prolonged (BP) QT: 450 msec to <=480 msec. Participants with abnormally low or high values were reported.
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Percentage of Participants With Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs parameters (pulse rate, diastolic and systolic blood pressure) were reported. Abnormality criteria: Pulse rate AL:<=45 bpm; Systolic blood pressure (SBP) AL: <=90 millimeters of mercury (mmHg), mild:>140 mmHg to <160 mmHg; moderate:>=160 mmHg to <180 mmHg; Diastolic blood pressure (DBP): AL: <=150 mmHg; mild:>90 mmHg to <100 mmHg; moderate: >=100 mmHg to <110 mmHg; severe:>=110 mmHg. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBsAg seroclearance 24 weeks after completion of all study intervention at Week 48 were reported. HBsAg seroclearance was defined as HBsAg (less than [<] lower limit of quantification LLOQ [0.05 IU/mL]). Responder was defined as a participant who achieved functional cure at Week 72. A participant was defined as having achieved functional cure at Week 72 if he/she: had met the criteria for stopping NA treatment at Week 48 and stopped treatment; had HBsAg seroclearance at Week 72 (that is, 24 weeks after stopping all study interventions); did not require NA re-treatment between Weeks 48 and 72. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
Week 72
Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBsAg seroclearance 48 weeks after completion of all study intervention at Week 48 were reported. HBsAg Seroclearance was defined as HBsAg \
Week 96
Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBV DNA \
Weeks 72 and 96
Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up
Percentage of participants meeting the NA treatment completion criteria during follow-up were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (<) 3*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) <10 international units per milliliter (IU/mL). A responder was defined as a participant who stopped NA at Week 48 and met the NA treatment completion criteria at any time during the follow-up phase, regardless of the treatment duration.
Week 48 up to Week 96
Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96
Percentage of participants with HBsAg seroclearance after completion of NA treatment at Weeks 60, 84, and 96 were reported. Seroclearance of HBsAg was defined as HBsAg level \
Weeks 60, 84, and 96
Percentage of Participants Who Required NA Re-treatment During Follow-up
Percentage of participants who required NA re-treatment during follow-up were reported. Responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. NA re-treatment criteria: (1) Re-start NA treatment immediately with signs of decreasing liver function based on laboratory findings (eg, International Normalized Ratio [INR], direct bilirubin) or clinical assessment (eg, ascites, hepatic encephalopathy). (2) Immediately with an HBV DNA value of >100,000 IU/mL (irrespective of confirmation and/or ALT increase). (3) With confirmed post-treatment HBeAg seroreversion (HBeAg positive after it was negative at NA completion) (4) With confirmed* post-treatment increases in HBV DNA >2,000 IU/mL and ALT >5x ULN (5) With confirmed* post-treatment increases in HBV DNA >20,000 IU/mL.
Week 48 up to Week 96
Percentage of Participants With Flares
Percentage of participants with flares (virologic, biochemical, and clinical) were reported. Virologic flare: confirmed HBV DNA >peak threshold ( 20,000 IU/mL 2,000 IU/mL and 200 IU/mL); biochemical Flare: confirmed ALT and/or AST increase of 3*ULN and 3*nadir; clinical flare: confirmed HBV DNA >peak threshold and confirmed ALT and/or AST increase of 3*ULN and 3*nadir. Virologic and clinical flare was assessed only for those participants who were off-treatment and had HBV DNA\
Follow-up phase (Week 48 up to Week 96)
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker
Number of participants with (sustained) reduction considering multiple markers were reported. HBV DNA results \
Weeks 12, 24, 36 and 48
Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as achieving HBsAg seroclearance (HBsAg [quantitative] <LLOQ [0.05 IU/mL]) together with an appearance of anti-HBs antibodies (baseline anti-HBs antibodies [quantitative] <LLOQ and a post-baseline assessment greater than or equal to [>=] LLOQ).
Weeks 48, 60, 72, and 96
Percentage of Participants With HBeAg Seroconversion
HBeAg seroconversion was defined as achieving HBeAg seroclearance (HBeAg [quantitative] \
Weeks 48, 60, 72, and 96
Change From Baseline in HBsAg Levels
Change from baseline in HBsAg levels was reported.
Baseline, Weeks 12, 24, 48, 60, 72, 96
Change From Baseline in HBeAg Levels
Change from baseline in HBeAg levels was reported.
Baseline, Weeks 12, 24, 48, 60, 72, 96
Change From Baseline in HBV DNA Levels
Change from baseline in HBV DNA levels were reported.
Baseline, Weeks 12, 24, 48, 60, 72, 96
Time to Achieve HBsAg Seroclearance
Time to HBsAg seroclearance (defined as HBsAg level \
Baseline (Day 1) up to Week 96
Time to Achieve HBeAg Seroclearance
Time to HBeAg seroclearance (defined as HBeAg level \
Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Levels <100 IU/mL
Percentage of participants with HBsAg levels <100 IU/mL was reported.
Baseline, Weeks 12, 24, 48, 60, 72, 96
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline
Percentage of participants with HBsAg levels >1 log10 IU/mL reduction from baseline was reported.
Weeks 12, 24, 48, 60, 72, 96
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ
Percentage of HBeAg-positive participants with HBeAg levels \
Weeks 12, 24, 48, 60, 72, 96
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL
Percentage of HBeAg-positive partcipants with HBeAg levels >1 log10 IU/mL were reported.
Weeks 12, 24, 48, 60, 72, 96
Percentage of Participants With HBV DNA Levels <LLOQ
Percentage of participants with HBV DNA levels \
Baseline, Weeks 12, 24, 48, 60, 72, 96
Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline
Mean change from baseline in ALT at EOT (Week 48) in participants with elevated ALT at baseline were reported.
Baseline and Week 48
Percentage of Participants With ALT Normalization
Percentage of participants with ALT normalization was reported. A participant with ALT elevation at baseline was considered to achieve ALT normalization if his/her ALT value was \
Baseline, Weeks 12, 24, 48, 60, 72, 96
Percentage of Participants With Virologic Breakthrough
Virologic breakthrough was defined as having a confirmed on-treatment HBV DNA increase by >1 log10 from nadir (that is, lowest value during treatment) or a confirmed HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level below the LLOQ (20 IU/mL). On-treatment was defined as the time period in which the participant received any of the study intervention.
Baseline (Day 1) up to Week 48
Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up
Percentage of participants with undetectable HBV DNA levels after re-start of NA treatment during follow-up was reported.
Week 48 up to Week 96
Los Angeles
California
90036
United States
Southern California GI and Liver Center
San Clemente
California
92673
United States
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C.
District of Columbia
20016
United States
Johns Hopkins University
Baltimore
Maryland
21287
United States
Washington University School Of Medicine
St Louis
Missouri
63110
United States
I.D. Care, Inc.
Hillsborough
New Jersey
08844
United States
NYU Hepatology Associates
New York
New York
10016
United States
Cliniques Universitaires Saint Luc
Brussels
1200
Belgium
UZ Antwerpen
Edegem
2650
Belgium
UZA-SGS
Edegem
2650
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
UZ Leuven
Leuven
3000
Belgium
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
Manaus
69040-000
Brazil
Universidade Federal da Bahia - Hospital Professor Edgard Santos
Salvador
40110-060
Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo
05403-000
Brazil
University of Calgary
Calgary
Alberta
T2N 4Z6
Canada
University of Alberta - Faculty of Medicine & Dentistry
Edmonton
Alberta
T6G 2G3
Canada
GI Research Institute (G.I.R.I.)
Vancouver
British Columbia
V6Z 2K5
Canada
Vancouver ID Research and Care Centre Society
Vancouver
British Columbia
V6Z2C7
Canada
Toronto General Hospital
Toronto
Ontario
ON M5G 2C4
Canada
Nanfang Hospital
Guangzhou
510515
China
FN Hradec Kralove
Hradec Králové
500 05
Czechia
RESEARCH SITE s.r.o.
Pilsen
32600
Czechia
KLIN MED s.r.o
Prague
120 00
Czechia
IKEM
Prague
140 21
Czechia
Hopital Beaujon
Clichy
92110
France
CHU de Grenoble Hopital Albert Michallon
Grenoble
38043
France
Hopital de La Croix Rousse
Lyon
69004
France
Hopital Saint Joseph
Marseille
13008
France
CHU de Nantes hotel Dieu
Nantes
44093
France
Hopital Saint-Antoine
Paris
75012
France
Chu Rennes Hopital Pontchaillou
Rennes
35033
France
Hopital Paul Brousse
Villejuif
94800
France
EPIMED GmbH
Berlin
10787
Germany
Universitatsklinikum Essen
Essen
45147
Germany
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
Frankfurt
60590
Germany
ICH Study Center GmbH & Co. KG
Hamburg
20146
Germany
University Medical Center
Hamburg
D-20246
Germany
Medizinische Hochschule Hannover
Hanover
30625
Germany
Universitaetsklinikum Leipzig
Leipzig
04103
Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz
55131
Germany
The University of Hong Kong
Hong Kong
Hong Kong
The Chinese University of Hong Kong
Shatin
Hong Kong
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina
98124
Italy
Irccs Ospedale Maggiore Di Milano
Milan
20122
Italy
Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
Modena
41126
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa
56124
Italy
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
Rome
00161
Italy
Tokyo Medical and Dental University Hospital
Bunkyō City
113 8519
Japan
Chiba University Hospital
Chiba
260 8677
Japan
Fukui-ken Saiseikai Hospital
Fukui
918-8503
Japan
Fukuyama City Hospital
Fukuyama
721-8511
Japan
Hiroshima University Hospital
Hiroshima
734 8551
Japan
Kagawa Prefectural Central Hospital
Kagawa
760-8557
Japan
Nara Medical University Hospital
Kashihara
634-8522
Japan
Musashino Red Cross Hospital
Musashino
180-8610
Japan
National Hospital Organization Nagasaki Medical Center
Nagasaki
856-8562
Japan
Nagoya City University Hospital
Nagoya
467 8602
Japan
The Hospital of Hyogo College of Medicine
Nishinomiya
663-8501
Japan
Hokkaido University Hospital
Sapporo
060-8648
Japan
Osaka University Hospital
Suita-shi
565-0871
Japan
Toranomon Hospital
Tokyo
105-8470
Japan
Fujita Health University Hospital
Toyoake
470-1192
Japan
Hospital Sultanah Bahiyah
Alor Star
05460
Malaysia
Hospital Selayang
Batu Caves
68100
Malaysia
Hospital University Sains Malaysia
Kota Bharu
16150
Malaysia
University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
Bydgoszcz
85-030
Poland
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
Gdansk
80-462
Poland
ID Clinic
Mysłowice
41-400
Poland
Wojewodzki Szpital Zakazny w Warszawie
Warsaw
01-201
Poland
SP ZOZ Wroclawskie Centrum Zdrowia
Wroclaw
50-136
Poland
Ural State Medical University
Chelyabinsk
454092
Russia
Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
Krasnoyarsk
660049
Russia
Clinic of the Modern Medicine
Moscow
121170
Russia
Medical Center SibNovoMed LLC
Novosibirsk
630005
Russia
St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
Saint Petersburg
190103
Russia
Clinical Infectious Diseases Hospital n. a. S.P. Botkin
Saint Petersburg
195067
Russia
Republican Clinical Infectious Hospital
Saint Petersburg
196645
Russia
Medical Company Hepatolog Ltd
Samara
443063
Russia
Smolensk Regional Clinical Hospital
Smolensk
214018
Russia
Stavropol State Medical University
Stavropol
355017
Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg
620102
Russia
Seoul National University Hospital
Seoul
03080
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Asan Medical Center
Seoul
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Hosp Clinic de Barcelona
Barcelona
08028
Spain
Hosp Univ Vall D Hebron
Barcelona
8035
Spain
Hosp. Univ. 12 de Octubre
Madrid
28041
Spain
Hospital Puerta De Hierro
Madrid
28222
Spain
Hosp. Univ. Marques de Valdecilla
Santander
39008
Spain
Hosp. Gral. Univ. Valencia
Valencia
46014
Spain
King Chulalongkorn Memorial Hospital
Bangkok
10500
Thailand
Siriraj Hospital
Bangkok
10700
Thailand
Chiang Mai University Hospital
Chiang Mai
50200
Thailand
Prince Of Songkla University
Songkhla
90110
Thailand
Hacettepe University Hospital
Ankara
06230
Turkey (Türkiye)
Ankara University Medical Faculty
Ankara
06620
Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara
6800
Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul
34098
Turkey (Türkiye)
Ege University Medical of Faculty, Department of Gastroenterology
Izmir
35100
Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon
61080
Turkey (Türkiye)
NHS Greater Glasgow and Clyde - Gartnavel General Hospital
Glasgow
G12 0YN
United Kingdom
Grahame Hayton Unit
London
E1 1BB
United Kingdom
Kings College Hospital
London
SE5 9RF
United Kingdom
St Georges University of London and St George's University Hospitals NHS Foundation Trust
London
SW17 0RE
United Kingdom
Derived
Yuen MF, Asselah T, Jacobson IM, Brunetto MR, Janssen HLA, Takehara T, Hou JL, Kakuda TN, Lambrecht T, Beumont M, Kalmeijer R, Guinard-Azadian C, Mayer C, Jezorwski J, Verbinnen T, Lenz O, Shukla U, Biermer M; REEF-1 Study Group. Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):790-802. doi: 10.1016/S2468-1253(23)00148-6. Epub 2023 Jul 10.
FG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
FG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
FG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
FG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
FG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
FG00095 subjects
FG00196 subjects
FG00293 subjects
FG00394 subjects
FG00448 subjects
FG00545 subjects
Double Blind Phase
FG00095 subjects
FG00196 subjects
FG00293 subjects
FG00393 subjects
FG00448 subjects
FG00545 subjects
Follow up Phase 1:
Included participants who did not meet NA treatment completion criteria or did not stop NA
FG00081 subjects
FG00170 subjects
FG00271 subjects
FG00385 subjects
FG00447 subjects
FG00544 subjects
Follow up Phase 2:
Included participants who met NA treatment completion criteria at Week 44 and stopped NA at Week 48
FG0008 subjects
FG00117 subjects
FG00215 subjects
FG0035 subjects
FG0040 subjects
FG0051 subjects
Follow up Phase 3:
Included participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up
FG0003 subjects
FG0018 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Extended Follow up
Included participants who completed NA treatment during the follow-up phase
FG0003 subjects
FG0017 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Treated
FG00095 subjects
FG00196 subjects
FG00293 subjects
FG00394 subjects
FG00448 subjects
FG00545 subjects
COMPLETED
FG00092 subjects
FG00190 subjects
FG00290 subjects
FG00385 subjects
FG00445 subjects
FG00545 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0039 subjects
FG0043 subjects
FG0050 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0037 subjects
FG004
Randomized and not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Intent to treat (ITT) set included all participants who were randomly assigned to any of the 6 intervention arms and received at least 1 dose of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Participants Received
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
BG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
BG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
BG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
BG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
BG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00095
BG00196
BG00293
BG00393
BG00448
BG00545
BG006470
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.8± 10.72
BG00142.9± 10.9
BG00243± 11.3
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Children (2-11 years)
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00135
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
BELGIUM
Title
Measurements
BG0004
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48
Percentage of participants meeting the NA treatment completion criteria at Week 48 were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (<) 3*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) <10 international units per milliliter (IU/mL). Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
Modified Intent-to-Treat (mITT) set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 48
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.4± 4.36(4.36 to 14.36)
OG00119.1± 12.76(12.76 to 27.06)
OG00216.3± 10.33(10.33 to 23.99)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG005
Mantel Haenszel
= 0.848
Difference of proportions
-2.3
2-Sided
90
-5.97
1.38
Superiority
OG000
OG005
Mantel Haenszel
= 0.027
Secondary
Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Safety analysis set included all participants who received at least one dose of any of the study treatments.
Posted
Number
Percentage of participants
Baseline up to Week 48
ID
Title
Description
OG000
Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
OG001
Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
Secondary
Follow-up Phase 1: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Safety analysis set included all participants who received at least one dose of any of the study treatments.
Posted
Number
Percentage of participants
From Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase and did not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG001
Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA
Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
Secondary
Follow-up Phase 2: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
Posted
Number
Percentage of participants
From Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: Follow up Phase 2: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
OG001
Arm 2: Follow up Phase 2: JNJ-73763989 (200mg) + Placebo + NA
Participants who received JNJ-73763989 100 mg along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
Secondary
Follow-up Phase 3: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
Posted
Number
Percentage of participants
From Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: Follow up Phase 3: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up followed-up till Week 96.
OG001
Arm 2: Follow up Period 3: JNJ-73763989 (200mg) + Placebo + NA
Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up were followed-up till Week 96.
Secondary
Extended Follow-up Phase: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase.
Posted
Number
Percentage of participants
Extended Follow up Week 1 to extended follow up Week 48
ID
Title
Description
OG000
Arm 1: Extended Follow up: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants received JNJ-73763989 100 mg along with JNJ-56136379 250 mg NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG001
Arm 2: Extended Follow Up: JNJ-73763989 (200 mg) + Placebo + NA
Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
Secondary
Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Safety analysis set included all participants who received at least one dose of any of the study treatments.
Posted
Number
Percentage of participants
Baseline up to Week 48
ID
Title
Description
OG000
Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
OG001
Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
Secondary
Follow-up Phase 1: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Safety analysis set included all participants who received at least one dose of any of the study treatments.
Posted
Number
Percentage of participants
From Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase and did not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG001
Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA
Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
Secondary
Follow-up Phase 2: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
Posted
Number
Percentage of participants
From Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: Follow up Phase 2: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
OG001
Arm 2: Follow up Phase 2: JNJ-73763989 (200mg) + Placebo + NA
Participants who received JNJ-73763989 100 mg along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
Secondary
Follow-up Phase 3: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
Posted
Number
Percentage of participants
From Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: Follow up Phase 3: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
OG001
Arm 2: Follow up Period 3: JNJ-73763989 (200mg) + Placebo + NA
Secondary
Extended Follow-up Phase: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase.
Posted
Number
Percentage of participants
Extended Follow up Week 1 to extended follow up Week 48
ID
Title
Description
OG000
Arm 1: Extended Follow up: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants received JNJ-73763989 100 mg along with JNJ-56136379 250 mg NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG001
Arm 2: Extended Follow Up: JNJ-73763989 (200mg) + Placebo + NA
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology)
Percentage of participants with abnormalities in clinical laboratory tests (hematology: Abnormally low [AL] and Abnormally high [AH] basophils, eosinophils, erthrocytes mean corpuscular hemoglobin concentration, erthrocytes mean corpuscular heamoglobin, erthrocytes mean corpuscular volume, erthrocytes, hematocrit, lymphocytes atypical, metamyelocytes, monocytes, myelocytes, neutrophils, segmented, reticulocytes) were reported. Abnormality was determined at the investigator's discretion. Here, M.C: Mean corpuscular. Participants with abnormally low or high values were reported.
Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories. Here 'n=0' signifies no participants were available for analysis at specified timepoints.
Posted
Number
Percentage of participants
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry)
Percentage of participants with abnormalities in clinical laboratory tests (Chemistry: abnormally high and serum alpha fetoprotein, serum chloride, Serum gamma glutamyl tranferase [GGT], Serum high density cholesterol [HDL] Cholesterol, Indirect Bilirubin, Lactate Dehydrogenase, Serum Protein, Urea Nitrogen) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories and "N" (number of participants analyzed) represents number of participants evaluable for this outcome measure.
Posted
Number
Percentage of participants
Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis)
Percentage of participants with abnormalities in clinical laboratory tests(Urinalysis: abnormally high and low urine granular casts, urine hyaline casts, Urine Leukocytes,Urine Specific Gravity,Urine Squamous Epithelial cell, Urine T.E Cells, Urine Transitinoal erythrocyte count [E.C],Urine Tubular erthrocyte count ) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories and "N" (number of participants analyzed) represents number of participants evaluable for this outcome measure. Here 'n=0' signifies no participants were available for analysis at specified timepoint.
Posted
Number
Percentage of participants
Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Abnormalities in Electrocardiogram (ECG)
Percentage of participants with abnormalities in ECG parameters (heart rate, PR interval, QRS duration, and QTcF interval) were reported. Abnormality criteria: Heart rate abnormally low (AL): <45 beats per minute (bpm); PR interval AH:>220 msec; QRS duration AH:>120 msec; QTcF borderline prolonged (BP) QT: 450 msec to <=480 msec. Participants with abnormally low or high values were reported.
Safety analysis set included all participants who received at least one dose of any of the study treatments. Here, 'N' (number of participant analysed) signifies number of participant who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participant evaluable for specified categories.
Posted
Number
Percentage of participants
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs parameters (pulse rate, diastolic and systolic blood pressure) were reported. Abnormality criteria: Pulse rate AL:<=45 bpm; Systolic blood pressure (SBP) AL: <=90 millimeters of mercury (mmHg), mild:>140 mmHg to <160 mmHg; moderate:>=160 mmHg to <180 mmHg; Diastolic blood pressure (DBP): AL: <=150 mmHg; mild:>90 mmHg to <100 mmHg; moderate: >=100 mmHg to <110 mmHg; severe:>=110 mmHg. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Safety analysis set included all participants who received at least one dose of any of the study treatments. Here, 'N' (number of subject analysed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represented number of participants evaluable for the specified categories.
Posted
Number
Percentage of participants
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBsAg seroclearance 24 weeks after completion of all study intervention at Week 48 were reported. HBsAg seroclearance was defined as HBsAg (less than [<] lower limit of quantification LLOQ [0.05 IU/mL]). Responder was defined as a participant who achieved functional cure at Week 72. A participant was defined as having achieved functional cure at Week 72 if he/she: had met the criteria for stopping NA treatment at Week 48 and stopped treatment; had HBsAg seroclearance at Week 72 (that is, 24 weeks after stopping all study interventions); did not require NA re-treatment between Weeks 48 and 72. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
mITT set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 72
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBsAg seroclearance 48 weeks after completion of all study intervention at Week 48 were reported. HBsAg Seroclearance was defined as HBsAg \
mITT analysis set included all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBV DNA \
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
90% Confidence Interval
Percentage of participants
Weeks 72 and 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up
Percentage of participants meeting the NA treatment completion criteria during follow-up were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (<) 3*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) <10 international units per milliliter (IU/mL). A responder was defined as a participant who stopped NA at Week 48 and met the NA treatment completion criteria at any time during the follow-up phase, regardless of the treatment duration.
mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96
Percentage of participants with HBsAg seroclearance after completion of NA treatment at Weeks 60, 84, and 96 were reported. Seroclearance of HBsAg was defined as HBsAg level \
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
90% Confidence Interval
Percentage of of participants
Weeks 60, 84, and 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants Who Required NA Re-treatment During Follow-up
Percentage of participants who required NA re-treatment during follow-up were reported. Responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. NA re-treatment criteria: (1) Re-start NA treatment immediately with signs of decreasing liver function based on laboratory findings (eg, International Normalized Ratio [INR], direct bilirubin) or clinical assessment (eg, ascites, hepatic encephalopathy). (2) Immediately with an HBV DNA value of >100,000 IU/mL (irrespective of confirmation and/or ALT increase). (3) With confirmed post-treatment HBeAg seroreversion (HBeAg positive after it was negative at NA completion) (4) With confirmed* post-treatment increases in HBV DNA >2,000 IU/mL and ALT >5x ULN (5) With confirmed* post-treatment increases in HBV DNA >20,000 IU/mL.
mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participant impacted by the pandemic defined as those participant who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Flares
Percentage of participants with flares (virologic, biochemical, and clinical) were reported. Virologic flare: confirmed HBV DNA >peak threshold ( 20,000 IU/mL 2,000 IU/mL and 200 IU/mL); biochemical Flare: confirmed ALT and/or AST increase of 3*ULN and 3*nadir; clinical flare: confirmed HBV DNA >peak threshold and confirmed ALT and/or AST increase of 3*ULN and 3*nadir. Virologic and clinical flare was assessed only for those participants who were off-treatment and had HBV DNA\
mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of participants evaluable for the specified categories.
Posted
Number
90% Confidence Interval
Percentage of participants
Follow-up phase (Week 48 up to Week 96)
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker
Number of participants with (sustained) reduction considering multiple markers were reported. HBV DNA results \
mITT population. Here, 'N' (number of participants analyzed) signifies number of participants with non-missing data for both blood markers at specified time point after stopping all study treatments (including NA), who also met NA treatment completion criteria and at least 24 week off-treatment data available; and 'n' (number analysed) represents number of participants evaluable at specified timepoints.
Posted
Count of Participants
Participants
Weeks 12, 24, 36 and 48
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as achieving HBsAg seroclearance (HBsAg [quantitative] <LLOQ [0.05 IU/mL]) together with an appearance of anti-HBs antibodies (baseline anti-HBs antibodies [quantitative] <LLOQ and a post-baseline assessment greater than or equal to [>=] LLOQ).
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Weeks 48, 60, 72, and 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBeAg Seroconversion
HBeAg seroconversion was defined as achieving HBeAg seroclearance (HBeAg [quantitative] \
mITT population. Here, 'N' (number of participants analyzed) signifies HbeAg positive participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Weeks 48, 60, 72, and 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Change From Baseline in HBsAg Levels
Change from baseline in HBsAg levels was reported.
mITT analysis set included all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Posted
Mean
Standard Deviation
Log10 international units per milliliter
Baseline, Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Change From Baseline in HBeAg Levels
Change from baseline in HBeAg levels was reported.
mITT analysis set: all HbeAg + participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline, Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Change From Baseline in HBV DNA Levels
Change from baseline in HBV DNA levels were reported.
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline, Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Time to Achieve HBsAg Seroclearance
Time to HBsAg seroclearance (defined as HBsAg level \
mITT set: participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. N (number of participants analyzed): participants who achieved seroclearance and were available for the analysis and '0' in the number of participants analyzed field signifies none of the participant achieved seroclearance.
Posted
Median
90% Confidence Interval
Weeks
Baseline (Day 1) up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Time to Achieve HBeAg Seroclearance
Time to HBeAg seroclearance (defined as HBeAg level \
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'Here, 'N' (number of participants analyzed) signifies HBeAg positive participants who achieved seroclearance and were available for the analysis
Posted
Median
90% Confidence Interval
Weeks
Baseline (Day 1) up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBsAg Levels <100 IU/mL
Percentage of participants with HBsAg levels <100 IU/mL was reported.
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Baseline, Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline
Percentage of participants with HBsAg levels >1 log10 IU/mL reduction from baseline was reported.
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of partcipants
Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ
Percentage of HBeAg-positive participants with HBeAg levels \
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL
Percentage of HBeAg-positive partcipants with HBeAg levels >1 log10 IU/mL were reported.
mITT population. Here, 'N' (number of participants analyzed) signifies HBeAg + participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With HBV DNA Levels <LLOQ
Percentage of participants with HBV DNA levels \
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Baseline, Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline
Mean change from baseline in ALT at EOT (Week 48) in participants with elevated ALT at baseline were reported.
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants with ALT elevation at baseline who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units per liter (U/L)
Baseline and Week 48
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With ALT Normalization
Percentage of participants with ALT normalization was reported. A participant with ALT elevation at baseline was considered to achieve ALT normalization if his/her ALT value was \
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
Posted
Number
Percentage of participants
Baseline, Weeks 12, 24, 48, 60, 72, 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Virologic Breakthrough
Virologic breakthrough was defined as having a confirmed on-treatment HBV DNA increase by >1 log10 from nadir (that is, lowest value during treatment) or a confirmed HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level below the LLOQ (20 IU/mL). On-treatment was defined as the time period in which the participant received any of the study intervention.
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44.
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline (Day 1) up to Week 48
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Secondary
Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up
Percentage of participants with undetectable HBV DNA levels after re-start of NA treatment during follow-up was reported.
mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 48 up to Week 96
ID
Title
Description
OG000
Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (<) 3*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Time Frame
Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48
Description
Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA
Participants received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks.
0
95
2
95
66
95
EG001
Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.
0
96
3
96
59
96
EG002
Arm 3: DB Phase: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks.
0
93
2
93
59
93
EG003
Arm 4: DB Phase: JNJ-73763989 (40 mg) + Placebo + NA
Participants received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.
0
93
1
93
60
93
EG004
Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA
Participants received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.
0
48
2
48
41
48
EG005
Arm 6: DB Phase: Placebo + Placebo + NA
Participants received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.
0
45
0
45
30
45
EG006
Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase and did not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
0
81
1
81
28
81
EG007
Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA
Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
0
70
5
70
28
70
EG008
Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA
Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
0
71
3
71
35
71
EG009
Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
0
85
1
85
32
85
EG010
Arm 5: Follow up Phase 1: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
0
47
1
47
26
47
EG011
Arm 6 :Follow up Phase 1: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and did not meet NA treatment completion criteria or did Not stop NA were followed up till week 96.
0
44
0
44
14
44
EG012
Arm 1: Follow up Phase 2: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
0
8
1
8
3
8
EG013
Arm 2: Follow up Phase 2: JNJ-73763989 (200mg) + Placebo + NA
Participants who received JNJ-73763989 100 mg along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
0
17
0
17
5
17
EG014
Arm 3: Follow up Phase 2: JNJ-73763989 (100 mg) + Placebo + NA
Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
0
15
0
15
9
15
EG015
Arm 4: Follow up Phase 2: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
0
5
0
5
3
5
EG016
Arm 5: Follow up Phase 2: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
0
0
0
0
0
0
EG017
Arm 6: Follow up Phase 2: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 and placebo matching to JNJ-56136379 along with NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
0
1
0
1
0
1
EG018
Arm 1: Follow up Phase 3: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up followed-up till Week 96.
0
3
1
3
1
3
EG019
Arm 2: Follow up Period 3: JNJ-73763989 (200mg) + Placebo + NA
Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up were followed-up till Week 96.
0
8
0
8
3
8
EG020
Arm 3: Follow up Phase 3: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
0
5
0
5
1
5
EG021
Arm 4: Follow up Phase 3: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up were followed-up till Week 96.
0
0
0
0
0
0
EG022
Arm 5: Follow up Phase 3: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
0
0
0
0
0
0
EG023
Arm 6: Follow up Phase 3: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
0
0
0
0
0
0
EG024
Arm 1: Extended Follow up: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
Participants received JNJ-73763989 100 mg along with JNJ-56136379 250 mg NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
0
3
0
3
2
3
EG025
Arm 2: Extended Follow Up: JNJ-73763989 (200 mg) + Placebo + NA
Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
0
7
1
7
5
7
EG026
Arm 3: Extended Follow up: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
0
5
2
5
5
5
EG027
Arm 4: Extended Follow Up: JNJ-73763989 (40 mg) + Placebo + NA
Participants received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
0
0
0
0
0
0
EG028
Arm 5: Extended Follow Up: Placebo + JNJ-56136379 250 mg + NA
Participants received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
0
0
0
0
0
0
EG029
Arm 6: Extended Follow Up: Placebo + Placebo + NA
Participants received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary Artery Disease
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG0030 affected93 at risk
EG0041 affected48 at risk
EG0050 affected45 at risk
EG0060 affected81 at risk
EG0070 affected70 at risk
EG0080 affected71 at risk
EG0090 affected85 at risk
EG0100 affected47 at risk
EG0110 affected44 at risk
EG0120 affected8 at risk
EG0130 affected17 at risk
EG0140 affected15 at risk
EG0150 affected5 at risk
EG0160 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected8 at risk
EG0200 affected5 at risk
EG0210 at risk
EG0220 at risk
EG0230 at risk
EG0240 affected3 at risk
EG0250 affected7 at risk
EG0260 affected5 at risk
EG0270 at risk
EG0280 at risk
EG0290 at risk
Retinal Detachment
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Gastric Polyps
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Gallbladder Cholesterolosis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Fracture Displacement
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Hepatocellular Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0012 affected96 at risk
EG0023 affected93 at risk
EG0033 affected93 at risk
EG0041 affected48 at risk
EG0053 affected45 at risk
EG0061 affected81 at risk
EG0071 affected70 at risk
EG0081 affected71 at risk
EG0090 affected85 at risk
EG0102 affected47 at risk
EG0110 affected44 at risk
EG0120 affected8 at risk
EG0130 affected17 at risk
EG0140 affected15 at risk
EG0150 affected5 at risk
EG0160 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected8 at risk
EG0200 affected5 at risk
EG0210 at risk
EG0220 at risk
EG0230 at risk
EG0240 affected3 at risk
EG0250 affected7 at risk
EG0260 affected5 at risk
EG0270 at risk
EG0280 at risk
EG0290 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Atrioventricular Block First Degree
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Supraventricular Extrasystoles
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Otosclerosis
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Thyroid Cyst
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Blepharospasm
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Chorioretinal Scar
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Photophobia
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Photopsia
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Strabismus
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Vision Blurred
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0012 affected96 at risk
EG0022 affected93 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0025 affected93 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0003 affected95 at risk
EG0013 affected96 at risk
EG0022 affected93 at risk
EG003
Abnormal Faeces
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Chronic Gastritis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0012 affected96 at risk
EG0020 affected93 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0003 affected95 at risk
EG0012 affected96 at risk
EG0023 affected93 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0004 affected95 at risk
EG0013 affected96 at risk
EG00210 affected93 at risk
EG003
Diarrhoea Haemorrhagic
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0013 affected96 at risk
EG0022 affected93 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Epigastric Discomfort
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Gastrointestinal Erosion
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Gingival Swelling
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0013 affected96 at risk
EG0021 affected93 at risk
EG003
Haemorrhoids Thrombosed
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0004 affected95 at risk
EG0017 affected96 at risk
EG0026 affected93 at risk
EG003
Tooth Disorder
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0012 affected96 at risk
EG0022 affected93 at risk
EG003
Asthenia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0015 affected96 at risk
EG0025 affected93 at risk
EG003
Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Chills
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Fatigue
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0007 affected95 at risk
EG0012 affected96 at risk
EG0023 affected93 at risk
EG003
Feeling Hot
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Injection Site Bruising
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Injection Site Erythema
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0022 affected93 at risk
EG003
Injection Site Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0010 affected96 at risk
EG0026 affected93 at risk
EG003
Injection Site Reaction
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0003 affected95 at risk
EG0012 affected96 at risk
EG0022 affected93 at risk
EG003
Malaise
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0014 affected96 at risk
EG0021 affected93 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Peripheral Swelling
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Pyrexia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Thirst
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Vaccination Site Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Deficiency of Bile Secretion
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hepatic Cyst
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0022 affected93 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Contrast Media Allergy
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Campylobacter Colitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0004 affected95 at risk
EG0014 affected96 at risk
EG0023 affected93 at risk
EG003
Ear Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Epididymitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Eyelid Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0012 affected96 at risk
EG0020 affected93 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Genital Herpes
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Helicobacter Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Localised Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0006 affected95 at risk
EG0014 affected96 at risk
EG0028 affected93 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0012 affected96 at risk
EG0021 affected93 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0012 affected96 at risk
EG0021 affected93 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Skin Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0013 affected96 at risk
EG0024 affected93 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0012 affected96 at risk
EG0022 affected93 at risk
EG003
Varicella
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Vulvovaginal Candidiasis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Animal Bite
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Traumatic Tooth Displacement
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Ulna Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Vaccination Complication
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected95 at risk
EG0013 affected96 at risk
EG0021 affected93 at risk
EG003
Amylase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0012 affected96 at risk
EG0020 affected93 at risk
EG003
Beta 2 Microglobulin Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Blood Bicarbonate Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0022 affected93 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Blood Uric Acid Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Coagulation Time Prolonged
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Creatinine Renal Clearance Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Glomerular Filtration Rate Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG00011 affected95 at risk
EG0012 affected96 at risk
EG0025 affected93 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Lipase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Serum Ferritin Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Transaminases Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Vitamin D Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0004 affected95 at risk
EG0013 affected96 at risk
EG0023 affected93 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected95 at risk
EG0015 affected96 at risk
EG0026 affected93 at risk
EG003
Joint Range of Motion Decreased
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0012 affected96 at risk
EG0020 affected93 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected95 at risk
EG0014 affected96 at risk
EG0024 affected93 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Pain in Jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Adenoma Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0022 affected93 at risk
EG003
Facial Spasm
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG00013 affected95 at risk
EG00112 affected96 at risk
EG00217 affected93 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Sleep Disorder
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Calculus Urinary
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0003 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Atrophic Vulvovaginitis
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Cervical Dysplasia
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Heavy Menstrual Bleeding
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Menstruation Irregular
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0012 affected96 at risk
EG0021 affected93 at risk
EG003
Pruritus Genital
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0006 affected95 at risk
EG0015 affected96 at risk
EG0023 affected93 at risk
EG003
Cystic Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0021 affected93 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0011 affected96 at risk
EG0023 affected93 at risk
EG003
Pulmonary Mass
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Respiratory Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected95 at risk
EG0011 affected96 at risk
EG0022 affected93 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0022 affected93 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Eczema Asteatotic
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0011 affected96 at risk
EG0020 affected93 at risk
EG003
Hyperkeratosis Follicularis Et Parafollicularis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected95 at risk
EG0012 affected96 at risk
EG0020 affected93 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected95 at risk
EG0012 affected96 at risk
EG0021 affected93 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0021 affected93 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Menopause
Social circumstances
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Essential Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0005 affected95 at risk
EG0013 affected96 at risk
EG0020 affected93 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected95 at risk
EG0010 affected96 at risk
EG0020 affected93 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days to allow for filing of a patent application.
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
91
OG00448
OG00545
OG0035.5± 2.19(2.19 to 11.21)
OG0040.0± 0.00(0.00 to 6.05)
OG0052.2± 0.11(0.11 to 10.11)
Difference of proportions
7.4
2-Sided
90
1.07
13.68
Superiority
OG000
OG004
Mantel Haenszel
= 0.917
Difference of proportions
9.1
2-Sided
90
4.16
14.07
Superiority
OG000
OG002
Mantel Haenszel
= 0.917
Difference of proportions
-6.7
2-Sided
90
-14.67
1.25
Superiority
OG002
Arm 3: DB Phase: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase.
OG003
Arm 4: DB Phase: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
OG004
Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
OG005
Arm 6: DB Phase: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
Units
Counts
Participants
OG00095
OG00196
OG00293
OG00393
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG00071.6
OG00164.6
OG00271.0
OG00374.2
OG00485.4
OG00566.7
OG002
Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA
Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG003
Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase and and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG004
Arm 5: Follow up Phase 1: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG005
Arm 6 :Follow up Phase 1: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and did not meet NA treatment completion criteria or did Not stop NA were followed up till week 96.
Units
Counts
Participants
OG00081
OG00170
OG00271
OG00385
OG00447
OG00544
Title
Denominators
Categories
Title
Measurements
OG00048.1
OG00145.7
OG00256.3
OG00344.7
OG00455.3
OG00531.8
OG002
Arm 3: Follow up Phase 2: JNJ-73763989 (100 mg) + Placebo + NA
Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
OG003
Arm 4: Follow up Phase 2: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
OG004
Arm 5: Follow up Phase 2: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
OG005
Arm 6: Follow up Phase 2: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 and placebo matching to JNJ-56136379 along with NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.
Units
Counts
Participants
OG0008
OG00117
OG00215
OG0035
OG0040
OG0051
Title
Denominators
Categories
Title
Measurements
OG00037.5
OG00129.4
OG00260.0
OG00360.0
OG0050
OG002
Arm 3: Follow up Phase 3: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
OG003
Arm 4: Follow up Phase 3: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up were followed-up till Week 96.
OG004
Arm 5: Follow up Phase 3: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
OG005
Arm 6: Follow up Phase 3: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
Units
Counts
Participants
OG0003
OG0018
OG0025
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00137.5
OG00220.0
OG002
Arm 3: Extended Follow up: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG003
Arm 4: Extended Follow Up: JNJ-73763989 (40 mg) + Placebo + NA
Participants received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG004
Arm 5: Extended Follow Up: Placebo + JNJ-56136379 250 mg + NA
Participants received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG005
Arm 6: Extended Follow Up: Placebo + Placebo + NA
Participants received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00171.4
OG002100.0
OG002
Arm 3: DB Phase: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase.
OG003
Arm 4: DB Phase: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
OG004
Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
OG005
Arm 6: DB Phase: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase.
Units
Counts
Participants
OG00095
OG00196
OG00293
OG00393
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG0002.1
OG0013.1
OG0022.2
OG0031.1
OG0044.2
OG0050
OG002
Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA
Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG003
Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.
OG004
Arm 5: Follow up Phase 1: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up tll Week 96.
OG005
Arm 6 :Follow up Phase 1: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and did not meet NA treatment completion criteria or did Not stop NA were followed up till week 96.
Units
Counts
Participants
OG00081
OG00170
OG00271
OG00385
OG00447
OG00544
Title
Denominators
Categories
Title
Measurements
OG0001.2
OG0017.1
OG0024.2
OG0031.2
OG0042.1
OG0050
OG002
Arm 3: Follow up Phase 2: JNJ-73763989 (100 mg) + Placebo + NA
Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria and stopped NA at Week 48 were followed-up till Week 96.
OG003
Arm 4: Follow up Phase 2: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria and stopped NA at Week 48 were followed-up till Week 96.
OG004
Arm 5: Follow up Phase 2: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria and stopped NA at Week 48 were followed-up till Week 96.
OG005
Arm 6: Follow up Phase 2: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 and placebo matching to JNJ-56136379 along with NA up to 48 weeks during double blind phase and who met NA treatment completion criteria and stopped NA at Week 48 were followed-up till Week 96.
Units
Counts
Participants
OG0008
OG00117
OG00215
OG0035
OG0040
OG0051
Title
Denominators
Categories
Title
Measurements
OG00012.5
OG0010
OG0020
OG0030
OG0050
Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up were followed-up till Week 96.
OG002
Arm 3: Follow up Phase 3: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
OG003
Arm 4: Follow up Phase 3: JNJ-73763989 (40 mg) + Placebo + NA
Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up were followed-up till Week 96.
OG004
Arm 5: Follow up Phase 3: Placebo + JNJ-56136379 250 mg + NA
Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
OG005
Arm 6: Follow up Phase 3: Placebo + Placebo + NA
Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.
Units
Counts
Participants
OG0003
OG0018
OG0025
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG0010
OG0020
Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG002
Arm 3: Extended Follow up: JNJ-73763989 (100 mg) + Placebo + NA
Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG003
Arm 4: Extended Follow Up: JNJ-73763989 (40 mg) + Placebo + NA
Participants received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG004
Arm 5: Extended Follow Up: Placebo + JNJ-56136379 250 mg + NA
Participants received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
OG005
Arm 6: Extended Follow Up: Placebo + Placebo + NA
Participants received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0000
OG00114.3
OG00240.0
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00093
OG00194
OG00293
OG00392
OG00448
OG00545
Title
Denominators
Categories
DB:Basophils AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
ParticipantsOG00448
ParticipantsOG00545
Title
Measurements
OG0000
OG0010
OG0020
OG003
DB:Basophils AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Basophils AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Basophils AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Eosinophils AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Eosinophils AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Eosinophils AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Eosinophils AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Ery. M.C HGB Conc. AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Ery. M.C HGB Conc. AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Ery. M.C HGB Conc. AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Ery. M.C HGB Conc. AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Ery. M.C Hemoglobin AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Ery. M.C Hemoglobin AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U::Ery. M.C Hemoglobin AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U::Ery. M.C Hemoglobin AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Ery. M.C Volume AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Ery. M.C Volume AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Ery. M.C Volume AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Ery. M.C Volume AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Erythrocytes AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Erythrocytes AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Erythrocytes AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Erythrocytes AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Hematocrit AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Hematocrit AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Hematocrit AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U: Hematocrit AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Lymphocytes Atypical AL
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0034
DB:Lymphocytes Atypical AH
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0034
F-U:Lymphocytes Atypical AL
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
F-U:Lymphocytes Atypical AH
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
DB:Lymphocyte Atypical/Leukocyte AL
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0034
DB:Lymphocyte Atypical/Leukocyte AH
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0034
F-U:LymphocyteAtypical/Leukocyte AL
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
F-U:LymphocyteAtypical/Leukocyte AH
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
F-U:Metamyelocytes AL
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
F-U:Metamyelocytes AH
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DB:Monocytes AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Monocytes AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Monocytes AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Monocytes AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Myelocytes AL
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
F-U:Myelocytes AH
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
DB:Neutrophils, Segmented AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Neutrophils, Segmented AH
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Neutrophils,Segmented AL
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
F-U:Neutrophils,Segmented AH
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00387
DB:Reticulocytes AL
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00291
ParticipantsOG00389
DB:Reticulocytes AH
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00291
ParticipantsOG00389
F-U:Reticulocytes AL
ParticipantsOG00092
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00386
F-U:Reticulocytes AH
ParticipantsOG00092
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00386
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00196
OG00293
OG00393
OG00448
OG00545
Title
Denominators
Categories
DB:Serum Alpha Fetoprotein AL
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00389
ParticipantsOG00446
ParticipantsOG00543
Title
Measurements
OG0000
OG0010
OG0020
OG003
DB:Serum Alpha Fetoprotein AH
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00389
F-U:Serum AlphaFetoprotein AL
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00285
ParticipantsOG00386
F-U:Serum AlphaFetoprotein AH
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00285
ParticipantsOG00386
F-U:Serum Chloride AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Serum Chloride AH
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB:Serum GGT AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB:Serum GGT AH
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
F-U:Serum GGT AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Serum GGT AH
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB:Serum HDL Cholesterol AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB:Serum HDL Cholesterol AH
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
F-U:Serum HDL Cholesterol AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Serum HDL Cholesterol AH
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB:Indirect Bilirubin AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB:Indirect Bilirubin AH
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
F-U:Indirect Bilirubin AL
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Indirect Bilirubin AH
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB:Lactate Dehydrogenase AL
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
DB:Lactate Dehydrogenase AH(
ParticipantsOG00093
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
F-U:Lactate Dehydrogenase AL
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Lactate Dehydrogenase AH
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB:Serum Protein AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB:Serum Protein AH
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
F-U:Serum Protein AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Serum Protein AH
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB:Urea Nitrogen AL
ParticipantsOG00093
ParticipantsOG00195
ParticipantsOG00293
ParticipantsOG00393
DB:Urea Nitrogen AH
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
F-U:Urea Nitrogen AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
F-U:Urea Nitrogen AH
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00061
OG00161
OG00253
OG00354
OG00429
OG00525
Title
Denominators
Categories
DB:Urine Granular Casts AL
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000
OG0030
DB:Urine Granular Casts AH
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
DB:Urine Hyaline Casts AL
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
DB:Urine Hyaline Casts AH
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
F-U:Urine Hyaline Casts AL
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
F-U:Urine Hyaline Casts AH
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DB:Urine Leukocytes AL
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00242
ParticipantsOG00339
DB:Urine Leukocytes AH
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00242
ParticipantsOG00339
F-U:Urine Leukocytes AL
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG00311
F-U:Urine Leukocytes AH
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG00311
DB:Urine Specific Gravity AL
ParticipantsOG00061
ParticipantsOG00161
ParticipantsOG00253
ParticipantsOG00354
DB:Urine Specific Gravity AH
ParticipantsOG00061
ParticipantsOG00161
ParticipantsOG00253
ParticipantsOG00354
F-U:Urine Specific Gravity AL
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG00218
ParticipantsOG00315
F-U:Urine Specific Gravity AH
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG00218
ParticipantsOG00315
DB:Urine Squamous Epithelial cell AL
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
DB:Urine Squamous Epithelial cellAH
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
DB:Urine T.E Cells AL
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
DB:Urine Transitinoal E.C AH
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
DB:Urine Tubular E.C AL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
DB:Urine Tubular E.C AH
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00093
OG00195
OG00291
OG00392
OG00447
OG00545
Title
Denominators
Categories
DB Phase: Heart Rate AL
ParticipantsOG00093
ParticipantsOG00195
ParticipantsOG00291
ParticipantsOG00392
ParticipantsOG00447
ParticipantsOG00545
Title
Measurements
OG0000
OG0012.1
OG0021.1
OG003
FU Phase: Heart Rate AL
ParticipantsOG00092
ParticipantsOG00184
ParticipantsOG00283
ParticipantsOG00384
DB Phase: PR interval AH
ParticipantsOG00093
ParticipantsOG00195
ParticipantsOG00291
ParticipantsOG00392
FU Phase: PR interval AH
ParticipantsOG00092
ParticipantsOG00184
ParticipantsOG00283
ParticipantsOG00384
DB Phase: QRS duration AH
ParticipantsOG00093
ParticipantsOG00195
ParticipantsOG00291
ParticipantsOG00392
FU Phase: QRS duration AH
ParticipantsOG00092
ParticipantsOG00184
ParticipantsOG00283
ParticipantsOG00384
DB Phase: QTcF interval BP-QT
ParticipantsOG00093
ParticipantsOG00195
ParticipantsOG00291
ParticipantsOG00392
FU Phase: QTcF interval BP-QT
ParticipantsOG00092
ParticipantsOG00184
ParticipantsOG00283
ParticipantsOG00384
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00196
OG00293
OG00393
OG00448
OG00545
Title
Denominators
Categories
DB:Pulse rate AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
ParticipantsOG00448
ParticipantsOG00545
Title
Measurements
OG0001.1
OG0014.2
OG0022.2
OG003
DB:Pulse rate AH
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
FU:Pulse rate AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
FU:Pulse rate AH
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB: DBP AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB: DBP mild
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB: DBP moderate
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB: DBP severe
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
FU: DBP AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
FU: DBP mild
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
FU: DBP moderate
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
DB: SBP AL
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB: SBP mild
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
DB: SBP moderate
ParticipantsOG00093
ParticipantsOG00196
ParticipantsOG00293
ParticipantsOG00393
FU: SBP AL
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
FU: SBP mild
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
FU: SBP moderate
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00388
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.00 to 3.14)
OG0010.0(0.00 to 3.14)
OG0020.0(0.00 to 3.20)
OG0030.0(0.00 to 3.24)
OG0040.0(0.00 to 6.05)
OG0052.2(0.11 to 10.11)
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.00(0.00 to 3.14)
OG0011.1± 0.05(0.05 to 4.95)
OG0020.0± 0.00(0.00 to 3.20)
OG0030.0± 0.00(0.00 to 3.24)
OG0040.0± 0.00(0.00 to 6.05)
OG0052.2± 0.11(0.11 to 10.11)
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Week 72
Title
Measurements
OG0005.3(2.12 to 10.86)
OG00116.0(10.10 to 23.50)
OG0027.6(3.63 to 13.82)
OG0031.1(0.06 to 5.11)
OG0040.0(0.00 to 6.05)
OG0054.4(0.80 to 13.34)
Week 96
Title
Measurements
OG0006.4(2.82 to 12.21)
OG0019.6(5.09 to 16.11)
OG0025.4(2.17 to 11.09)
OG003
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG00011.7(6.70 to 18.63)
OG00127.7(20.16 to 36.25)
OG00216.3(10.33 to 23.99)
OG0034.4(1.52 to 9.78)
OG0040.0(0.00 to 6.05)
OG0052.2(0.11 to 10.11)
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Week 60
ParticipantsOG0009
ParticipantsOG00122
ParticipantsOG00218
ParticipantsOG0035
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG0000.0(0.00 to 28.31)
OG0019.1(1.64 to 25.95)
OG0020.0(0.00 to 15.33)
OG003
Week 84
ParticipantsOG00010
ParticipantsOG00122
ParticipantsOG00214
ParticipantsOG0035
Week 96
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00292
ParticipantsOG00391
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG0001.1± 0.05(0.05 to 4.95)
OG0011.1± 0.05(0.05 to 4.95)
OG0022.2± 0.39(0.39 to 6.69)
OG0030.0± 0.00(0.00 to 3.24)
OG0040.0± 0.00(0.00 to 6.05)
OG0050.0± 0.00(0.00 to 6.44)
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Biochemical: On NA
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00292
ParticipantsOG00391
ParticipantsOG00448
ParticipantsOG00545
Title
Measurements
OG0000.0(0.00 to 3.14)
OG0010.0(0.00 to 3.14)
OG0020.0(0.00 to 3.20)
OG003
Biochemical: Off NA
ParticipantsOG00033
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00318
Virologic HBVDNA>200:Off NA
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00314
Virologic HBVDNA>2000:Off NA
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00314
Virologic HBVDNA>20000:Off NA
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00314
Clinical HBVDNA>200:Off NA
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00314
Clinical HBVDNA>2000:Off NA
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG00314
Clinical HBVDNA>20000:Off NA
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00214
ParticipantsOG0039
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00010
OG00125
OG00218
OG0035
OG0041
OG0051
Title
Denominators
Categories
Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG00217
ParticipantsOG0035
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG0000
OG0011
OG0020
OG003
Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG00217
ParticipantsOG003
Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG00010
ParticipantsOG00124
ParticipantsOG00216
ParticipantsOG003
Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG00010
ParticipantsOG00124
ParticipantsOG00216
ParticipantsOG003
Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG0009
ParticipantsOG00123
ParticipantsOG00218
ParticipantsOG003
Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG0009
ParticipantsOG00123
ParticipantsOG00218
ParticipantsOG003
Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG00010
ParticipantsOG00123
ParticipantsOG00218
ParticipantsOG003
Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected
ParticipantsOG00010
ParticipantsOG00123
ParticipantsOG00218
ParticipantsOG003
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00087
OG00189
OG00283
OG00385
OG00445
OG00542
Title
Denominators
Categories
Week 48
ParticipantsOG00086
ParticipantsOG00189
ParticipantsOG00283
ParticipantsOG00385
ParticipantsOG00444
ParticipantsOG00542
Title
Measurements
OG0000.0
OG0011.1
OG0020.0
OG003
Week 60
ParticipantsOG00085
ParticipantsOG00183
ParticipantsOG00278
ParticipantsOG00381
Week 72
ParticipantsOG00083
ParticipantsOG00182
ParticipantsOG00276
ParticipantsOG00382
Week 96
ParticipantsOG00087
ParticipantsOG00181
ParticipantsOG00280
ParticipantsOG00380
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00025
OG00128
OG00223
OG00325
OG00414
OG00511
Title
Denominators
Categories
Week 48
ParticipantsOG00025
ParticipantsOG00128
ParticipantsOG00223
ParticipantsOG00324
ParticipantsOG00413
ParticipantsOG00511
Title
Measurements
OG0004.0
OG0013.6
OG0028.7
OG003
Week 60
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00222
ParticipantsOG00323
Week 72
ParticipantsOG00024
ParticipantsOG00127
ParticipantsOG00222
ParticipantsOG00325
Week 96
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00324
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Baseline
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00292
ParticipantsOG00391
ParticipantsOG00448
ParticipantsOG00545
Title
Measurements
OG0003.66± 0.691
OG0013.83± 0.721
OG0023.70± 0.778
OG003
Week 12
ParticipantsOG00092
ParticipantsOG00192
ParticipantsOG00286
ParticipantsOG00388
Week 24
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00288
ParticipantsOG00388
Week 48
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00386
Week 60
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00284
ParticipantsOG00383
Week 72
ParticipantsOG00085
ParticipantsOG00183
ParticipantsOG00282
ParticipantsOG00384
Week 96
ParticipantsOG00089
ParticipantsOG00182
ParticipantsOG00285
ParticipantsOG00382
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00027
OG00130
OG00225
OG00330
OG00415
OG00513
Title
Denominators
Categories
Baseline
ParticipantsOG00027
ParticipantsOG00130
ParticipantsOG00225
ParticipantsOG00330
ParticipantsOG00415
ParticipantsOG00513
Title
Measurements
OG0001.22± 1.494
OG0011.60± 1.449
OG0021.68± 1.540
OG003
Week 12
ParticipantsOG00027
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00329
Week 24
ParticipantsOG00027
ParticipantsOG00129
ParticipantsOG00225
ParticipantsOG00330
Week 48
ParticipantsOG00026
ParticipantsOG00128
ParticipantsOG00224
ParticipantsOG00327
Week 60
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00224
ParticipantsOG00327
Week 72
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00328
Week 96
ParticipantsOG00026
ParticipantsOG00127
ParticipantsOG00224
ParticipantsOG00326
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00033
OG00135
OG00233
OG00333
OG00418
OG00516
Title
Denominators
Categories
Baseline
ParticipantsOG00033
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00418
ParticipantsOG00516
Title
Measurements
OG0005.97± 1.989
OG0016.64± 1.972
OG0026.34± 1.778
OG003
Week 12
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00331
Week 24
ParticipantsOG00032
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00331
Week 48
ParticipantsOG00030
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00330
Week 60
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00228
ParticipantsOG00331
Week 72
ParticipantsOG00030
ParticipantsOG00131
ParticipantsOG00229
ParticipantsOG00331
Week 96
ParticipantsOG00031
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00328
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG0000
OG0015
OG0023
OG0030
OG0040
OG0051
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)Here "NA" signifies that median and 90% confidence interval (CI) could not be calculated due to insufficient number of participants with events.
OG002NA(NA to NA)Here "NA" signifies that median and 90% CI could not be calculated due to insufficient number of participants with events.
OG005NA(NA to NA)Here "NA" signifies that median and 90% CI could not be calculated due to insufficient number of participants with events.
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG0006
OG0015
OG0027
OG0033
OG0044
OG0052
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Here "NA" signifies that median, lower and upper limit of 90% confidence interval (CI) could not be calculated due to insufficient number of participants with events.
OG001NA(NA to NA)Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.
OG002NA(NA to NA)Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.
OG003NA(NA to NA)Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.
OG004NA(NA to NA)Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.
OG005NA(NA to NA)Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Baseline
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00292
ParticipantsOG00391
ParticipantsOG00448
ParticipantsOG00545
Title
Measurements
OG0000
OG0011.1
OG0021.1
OG003
Week 12
ParticipantsOG00092
ParticipantsOG00192
ParticipantsOG00286
ParticipantsOG00388
Week 24
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00288
ParticipantsOG00388
Week 48
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00386
Week 60
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00284
ParticipantsOG00383
Week 72
ParticipantsOG00085
ParticipantsOG00183
ParticipantsOG00282
ParticipantsOG00384
Week 96
ParticipantsOG00089
ParticipantsOG00182
ParticipantsOG00285
ParticipantsOG00382
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00092
OG00192
OG00288
OG00388
OG00446
OG00545
Title
Denominators
Categories
Week 12
ParticipantsOG00092
ParticipantsOG00192
ParticipantsOG00286
ParticipantsOG00388
ParticipantsOG00445
ParticipantsOG00545
Title
Measurements
OG00040.2
OG00172.8
OG00260.5
OG003
Week 24
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00288
ParticipantsOG00388
Week 48
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00386
Week 60
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00284
ParticipantsOG00383
Week 72
ParticipantsOG00085
ParticipantsOG00183
ParticipantsOG00282
ParticipantsOG00384
Week 96
ParticipantsOG00089
ParticipantsOG00182
ParticipantsOG00285
ParticipantsOG00382
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00027
OG00129
OG00225
OG00330
OG00415
OG00513
Title
Denominators
Categories
Week 12
ParticipantsOG00027
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00329
ParticipantsOG00413
ParticipantsOG00510
Title
Measurements
OG0007.4
OG0013.7
OG00217.4
OG003
Week 24
ParticipantsOG00027
ParticipantsOG00129
ParticipantsOG00225
ParticipantsOG00330
Week 48
ParticipantsOG00026
ParticipantsOG00128
ParticipantsOG00224
ParticipantsOG00327
Week 60
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00224
ParticipantsOG00327
Week 72
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00328
Week 96
ParticipantsOG00026
ParticipantsOG00127
ParticipantsOG00224
ParticipantsOG00326
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00027
OG00129
OG00225
OG00330
OG00415
OG00513
Title
Denominators
Categories
Week 12
ParticipantsOG00027
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00329
ParticipantsOG00413
ParticipantsOG00510
Title
Measurements
OG00033.3
OG00133.3
OG00239.1
OG003
Week 24
ParticipantsOG00027
ParticipantsOG00129
ParticipantsOG00225
ParticipantsOG00330
Week 48
ParticipantsOG00026
ParticipantsOG00128
ParticipantsOG00224
ParticipantsOG00327
Week 60
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00224
ParticipantsOG00327
Week 72
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00223
ParticipantsOG00328
Week 96
ParticipantsOG00026
ParticipantsOG00127
ParticipantsOG00224
ParticipantsOG00326
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Baseline
ParticipantsOG00094
ParticipantsOG00194
ParticipantsOG00292
ParticipantsOG00391
ParticipantsOG00448
ParticipantsOG00545
Title
Measurements
OG00064.4
OG00160.4
OG00263.7
OG003
Week 12
ParticipantsOG00092
ParticipantsOG00192
ParticipantsOG00286
ParticipantsOG00388
Week 24
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00288
ParticipantsOG00388
Week 48
ParticipantsOG00088
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00387
Week 60
ParticipantsOG00088
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00385
Week 72
ParticipantsOG00086
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00384
Week 96
ParticipantsOG00089
ParticipantsOG00182
ParticipantsOG00285
ParticipantsOG00380
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00035
OG00132
OG00237
OG00334
OG00419
OG00518
Title
Denominators
Categories
Title
Measurements
OG000-72.77± 106.851(106.851 to )
OG001-65.47± 110.213(110.213 to )
OG002-37.51± 63.468(63.468 to )
OG003-42.53± 41.767(41.767 to )
OG004-17.68± 272.44(272.44 to )
OG005-49.28± 85.374(85.374 to )
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00036
OG00132
OG00237
OG00334
OG00419
OG00518
Title
Denominators
Categories
Baseline
ParticipantsOG00036
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00334
ParticipantsOG00419
ParticipantsOG00518
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 12 On-treatment
ParticipantsOG00035
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG00331
Week 24 On-treatment
ParticipantsOG00034
ParticipantsOG00130
ParticipantsOG00236
ParticipantsOG00333
Week 48 On-treatment
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG00331
Week 60 On-treatment
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00333
Week 72 On-treatment
ParticipantsOG00032
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00333
Week 96 On-treatment
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00234
ParticipantsOG00330
Week 60 Off-treatment
ParticipantsOG00033
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00333
Week 72 Off-treatment
ParticipantsOG00032
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00333
Week 96 Off-treatment
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00234
ParticipantsOG00330
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Units
Counts
Participants
OG00094
OG00194
OG00292
OG00391
OG00448
OG00545
Title
Denominators
Categories
Title
Measurements
OG0002.1± 0.38(0.38 to 6.55)
OG0012.1± 0.38(0.38 to 6.55)
OG0022.2± 0.39(0.39 to 6.69)
OG0032.2± 0.39(0.39 to 6.76)
OG0040.0± 0.00(0.00 to 6.05)
OG0052.2± 0.11(0.11 to 10.11)
OG001
Arm 2: JNJ-73763989 200 mg + Placebo + NA
Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG002
Arm 3: JNJ-73763989 100 mg + Placebo + NA
Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG003
Arm 4: JNJ-73763989 40 mg + Placebo + NA
Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG004
Arm 5: Placebo + JNJ-56136379 250 mg + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
OG005
Arm 6: Placebo + Placebo + NA
Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT <3*ULN, HBV DNA < LLOQ, HBeAg negative, HBsAg <10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).