A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, N... | NCT04439539 | Trialant
NCT04439539
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Jun 24, 2025Actual
Enrollment
54Actual
Phase
Phase 2
Conditions
Hepatitis B, Chronic
Interventions
JNJ-73763989
PegIFN-alpha-2a
Tenofovir disoproxil
Tenofovir alafenamide
JNJ-56136379
Countries
United States
Canada
France
Germany
Japan
Russia
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04439539
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108815
Secondary IDs
ID
Type
Description
Link
73763989PAHPB2005
Other Identifier
Janssen Research & Development, LLC
2019-004978-26
EudraCT Number
Brief Title
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
Official Title
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jun 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
Sep 14, 2020Actual
Primary Completion Date
Aug 29, 2023Actual
Completion Date
Feb 13, 2024Actual
First Submitted Date
Jun 18, 2020
First Submission Date that Met QC Criteria
Jun 18, 2020
First Posted Date
Jun 19, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 27, 2024
Results First Submitted that Met QC Criteria
Aug 27, 2024
Results First Posted Date
Sep 19, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 23, 2025
Last Update Posted Date
Jun 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (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 a ribonucleic acid interference (RNAi) mechanism. JNJ-56136379 is an orally administered capsid assembly modulator (CAM) that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + PegIFN-alpha-2a + NA with or without JNJ-56136379 in participants with hepatitis B e antigen (HBeAg) positive chronic infection. The study will be conducted in 4 phases: a screening phase, an induction phase with flexible duration, a consolidation phase with or without PegIFN-α2a and a follow-up phase. Safety assessments will include Adverse Events (AEs), serious AEs of the study interventions, clinical laboratory tests, Electrocardiograms (ECGs), vital signs, and physical examinations. The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but was discontinued as per amendment 6 of 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
54Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
Experimental
During the Induction phase, participants will receive JNJ-73763989 subcutaneously along with JNJ-56136379 tablet orally with NA (either tenofovir disoproxil or tenofovir alafenamide tablets orally) treatment. At the start of consolidation phase, participants will be randomized to receive PegIFN-alpha-2a subcutaneously in addition to JNJ-73763989 and JNJ-56136379 with NA in arm 1 and arm 2 (without PegIFN-alpha-2a). According to predefined criteria NA treatment may be continued during the follow up (FU) phase.
Drug: JNJ-73763989
Drug: PegIFN-alpha-2a
Drug: Tenofovir disoproxil
Drug: Tenofovir alafenamide
Drug: JNJ-56136379
Cohort 2: Participants Enrolled After Protocol Amendment 5 is in Effect
Experimental
Following implementation of protocol amendment- 5 and 6, all participants will receive JNJ-73763989 subcutaneously along with NA (tenofovir disoproxil tablets orally) for 36 weeks (induction phase). In the consolidation phase, participants will receive PegIFN-alpha-2a subcutaneously in addition to JNJ-73763989 and NA for 12 weeks. According to predefined criteria NA treatment may be continued during the follow up (FU) phase. JNJ-56136379 (JNJ-6379) was discontinued as per amendment 6 of the study.
Drug: JNJ-73763989
Drug: PegIFN-alpha-2a
Drug: Tenofovir disoproxil
Interventions
Name
Type
Description
Arm Group Labels
Other Names
JNJ-73763989
Drug
JNJ-73763989 injection will be administered subcutaneously.
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
Cohort 2: Participants Enrolled After Protocol Amendment 5 is in Effect
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment
Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \
At follow-up (FU) phase Week 24
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Currently not treated chronic hepatitis B virus (HBV) infection with alanine transaminase (ALT) less than (<) 2* upper limit of normal (ULN) at screening and HBV deoxyribonucleic acid (DNA) greater than or equal to (>=) 20,000 international units per milliliter (IU/mL)
Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than or equal to (<=) 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 or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
Evidence of liver disease of non-HBV etiology
Participants with a history of malignancy within 5 years before screening
Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
Contraindications to the use of PegIFN-α2a
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Kennedy PTF, Fung S, Buti M, Yilmaz G, Chuang WL, Asselah T, Kurosaki M, Jezorwski J, Klyashtornyy V, Verbinnen T, Kakuda TN, Lenz O, Guinard-Azadian C, Biermer M. Peginterferon alpha-2a add-on to siRNA JNJ-73763989 in untreated patients with HBeAg-positive chronic hepatitis B virus (HBV) infection: the phase 2 REEF-IT study. Gut. 2026 Apr 7;75(5):1043-1054. doi: 10.1136/gutjnl-2025-336592.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
Response-guided treatment (RGT): Hepatitis B surface antigen (HBsAg) less than (<) 10 international unit per millilitre (IU/mL). Post PA 5, RGT criterion was removed. Nucleos(t)ide (NA) treatment completion criteria: HBsAg <10 IU/mL, HB envelop antigen (HBeAg)-negative, and HB virus deoxyribonucleic acid (HBV DNA) \
Recruitment Details
Per protocol amendment (PA) 6, all participants stopped JNJ-56136379 (JNJ-6379) treatment and switched to single-arm study design: JNJ-73763989 (JNJ-3989) plus nucleos(t)ide analog (NA; tenofovir disoproxil/tenofovir Alafenamide) plus pegylated interferon alpha-2a (PegIFN-alpha-2a). The Study had of 3 phases: induction phase (IP), consolidation phase (CP) and follow-up (FU) phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
Periods
Title
Milestones
Reasons Not Completed
IP:Day 1-Week 36(Post-PA5)/52(Prior-PA5)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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 25, 2021
Aug 27, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
JNJ-3989
PegIFN-alpha-2a
Drug
PegIFN-alpha-2a injection will be administered subcutaneously.
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
Cohort 2: Participants Enrolled After Protocol Amendment 5 is in Effect
Tenofovir disoproxil
Drug
Tenofovir disoproxil film-coated tablet will be administered orally.
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
Cohort 2: Participants Enrolled After Protocol Amendment 5 is in Effect
Tenofovir alafenamide
Drug
Tenofovir alafenamide film-coated tablet will be administered orally.
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
JNJ-56136379
Drug
JNJ-56136379 will be administered orally.
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
JNJ-6379
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Number of participants with TESAEs were reported. was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Clinical laboratory test parameters were Hematology: absolute lymphocyte count, absolute neutrophil count (ANC), hemoglobin, Neutrophils Band Form, Neutrophils segmented, white blood cells (WBC) decreased, ; Chemistry: alanine aminotransferase (ALT) & serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT), cholesterol (fasting), creatinine Kinase, creatinine, GFR from Creatinine Adjusted for BSA, GFR from Cystatin C Adjusted for BSA, low-density lipoprotein (LDL), triglycerides (fasting); Urinalysis: glycosuria. DAIDS toxicity grades: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Number of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure.
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)
Number of participants with worst treatment-emergent abnormality in ECG were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. ECG parameters included heart rate (HR; abnormally low, HR <45 beats per minute (bpm) and (abnormally high HR>=120 bpm; PR interval abnormally high >220 milliseconds (ms): QRS interval abnormally high >=120 ms; QT corrected (Fridericia QTcF) categories; borderline prolonged QTc interval <450 to <=480 ms), prolonged QTc interval <480 to <=500 ms) and pathologically prolonged QTc interval >500 ms).
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Number of participants with worst treatment-emergent abnormalities in vital signs were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. Abnormalities in vital signs included abnormal pulse rate (PR); abnormally low, <=45 bpm and abnormally high >=120 bpm; diastolic blood pressure (DBP) abnormally low <=50 mmHg, systolic blood pressure (SBP) abnormally low <=90 mmHg. Additionally, abnormal low SBP and DBP were <=50 mmHg and <+90 mmHg. Only those categories in which at least one participant had data were reported.
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Number of Participants With Clinically Important Abnormalities in Physical Examination
Number of participants with clinically important treatment-emergent abnormalities in physical examination were reported.
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)
Percentage of participants who reached HBsAg <10 IU/mL at the end induction phase were reported.
At IP Week 36 and EOI; anytime up to IP Week 52 for Cohort 1; up to IP Week 36 for Cohort 2
Time to Achieve First Occurrence of HBsAg <10 IU/mL
Time to achieve first occurrence of HBsAg <10 IU/mL were reported. Time to HBsAg <10 IU/mL was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg <10 IU/mL. Kaplan-Meier method was used for the estimation.
From Baseline (Day 1 of IP) up to Follow-up phase Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase
Percentage of participants meeting the protocol-defined NA treatment completion criteria at end of consolidation were reported. NA treatment completion criteria at CP Week 12 was defined as HBsAg <10 IU/mL; HBeAg-negative; HBV DNA <20 IU/mL, (that is, LLOQ); alanine aminotransferase(ALT) <3*ULN.
At CP Week 12 (for Cohort 1 and 2)
FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
Percentage of participants with HBsAg seroclearance 48 weeks after stopping all study interventions at the consolidation phase and without restarting NA treatment during follow up phase were reported. HBsAg seroclearance was defined as (quantitative) HBsAg < LLOQ (HBsAg 0.05 IU/mL).
FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
Percentage of participants with HBV DNA \
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase
Number of participants with off-treatment virologic HBV flares were reported. Virologic flare was defined as confirmed HBV DNA >peak threshold (lowest peak to qualify as virologic flare was HBV DNA >200 IU/mL) in participants who were off-treatment and had HBV DNA \
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase
Number of participants with off-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA).
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase
Number of participants with on-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. On-treatment was defined as the time period during which the participant received any of the study drugs.
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase
Clinical flares occurred either when a virologic flare (confirmed HBV DNA >peak threshold) & biochemical flare (ALT and/or AST >=3*ULN & >=3*nadir [lowest value observed during off-treatment period up to time point of meeting the flare criteria]) overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. The HBV DNA thresholds were: 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that criteria was fulfilled at 2 or more consecutive time points or at last observed time point. Off-treatment was defined as time period after stopping all study drugs (including NA). The start date of a clinical flare was minimum start date of virologic flare and biochemical flare.
FU phase: FU Week 1 up to FU Week 48(up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase
Percentage of participants who required NA re-treatment during follow-up phase were reported. A 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.
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per Definition 1) were reported. Sustained HBsAg response (definition 1) was defined as: For participants with FU Week 48 data: participants who had a >1 log10 decline from baseline in HBsAg and HBsAg <000 IU/mL at FU Week 48. For participants without FU Week 48 data: participants who had a HBsAg decline from baseline of >2 log10 at FU Week 24 or >1.5 log10 at FU Week 36 (most recent value used) and had HBsAg <1000 IU/mL at the last available timepoint.
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per Definition 2) were reported. Sustained HBsAg response (per Definition 2) was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was <0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was <0.2.
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per definition 3) were reported. Sustained HBsAg response (per Definition 3) was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was <0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was <0.2 and had an HBsAg <1000 IU/mL at the last available timepoint.
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response per Definition 4 were reported. Sustained HBsAg response (per Definition 4) was defined as stable level, decreasing level, and increasing level. Stable level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was within 0.2 log10. Decreasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was less than -0.2 log10. Increasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was more than 0.2 log10.
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48
Percentage of Participants with HBsAg Seroclearance were reported. HBsAg seroclearance was defined as (quantitative) HBsAg level \
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48
Percentage of participants with HBeAg seroclearance were reported. HBeAg seroclearance was defined as (quantitative) HBeAg levels \
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants With HBsAg Seroconversion
Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg <LLOQ [<0.05 IU/mL]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies [quantitative] <LLOQ [<5 milli-international units per milliliter (mIU/mL)] and a post-baseline assessment >=LLOQ [>=5 mIU/mL]).
IP Week 24; CP: Week 12, FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Percentage of Participants With HBeAg Seroconversion
Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as [quantitative] HBeAg \
CP: Week 12; FU phase: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Change From Baseline Over Time in HBsAg Levels
Change from baseline over time in HBsAg levels at specified timepoints were reported
Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg \
From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Time to Achieve First HBeAg Seroclearance
Time to achieve first occurrence of HBeAg seroclearance (HBeAg \
From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Time to Achieve First HBV DNA <LLOQ
Time to achieve first occurrence of HBV DNA < LLOQ (<20 IU/mL) were reported. Time to first occurrence of the HBV DNA < LLOQ was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA < LLOQ.
From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Percentage of Participants With HBeAg Levels Below Different Cut-offs
Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were : \
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level < LLOQ (<20 IU/mL) or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level \
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up
Percentage of participants who reached HBV DNA undetectability after re-start of NA treatment during follow-up were reported. Undetectability of HBV DNA was defined as HBV DNA\
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Cmax of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Noncompartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules
IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules.
IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Plasma concentration 24 hours after administration (C24h) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted to analyze C24h of JNJ-73763989 and its molecules.
IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (molecules:JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted toanalyze AUC0 to 24h of JNJ-73763989 and its molecules.
IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit
Pittsburgh
Pennsylvania
15213
United States
Liver Institute Northwest
Seattle
Washington
98105
United States
University of Calgary
Calgary
Alberta
T2N 4Z6
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
Hopital Beaujon
Clichy
92110
France
CHU de Grenoble Hopital Albert Michallon
Grenoble
38043
France
Hopital de La Croix Rousse
Lyon
69004
France
CHU Nantes - Hotel Dieu
Nantes
44093
France
CHU Hopital Saint Antoine
Paris
75012
France
Chu Rennes Hopital Pontchaillou
Rennes
35033
France
CHU Nancy Brabois
Vandœuvre-lès-Nancy
54511
France
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin
10439
Germany
Universitatsklinikum Essen
Essen
45122
Germany
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
Frankfurt
60590
Germany
Medizinische Hochschule Hannover
Hanover
30625
Germany
Hiroshima University Hospital
Hiroshima
734 8551
Japan
Nara Medical University Hospital
Kashihara
634-8522
Japan
Musashino Red Cross Hospital
Musashino
180-8610
Japan
Nagoya City University Hospital
Nagoya
467 8602
Japan
Yokohama City University Medical Center
Yokohama
232 0024
Japan
Irkutsk State Medical University
Irkutsk
664003
Russia
Republic Clinical Infectious Hospital n.a. AF Agafonov
Kazan'
420140
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
Medical Company Hepatolog Ltd
Samara
443045
Russia
Smolensk Regional Clinical Hospital
Smolensk
214018
Russia
Stavropol State Medical University
Stavropol
355017
Russia
Hosp Clinic de Barcelona
Barcelona
8028
Spain
Hosp Univ Vall D Hebron
Barcelona
8035
Spain
Hosp. Gral. Univ. Valencia
Valencia
46014
Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
80756
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
National Cheng Kung University Hospital
Tainan
70403
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Hacettepe University Hospital
Ankara
06230
Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul
34098
Turkey (Türkiye)
Umraniye Training and Research Hospital
Istanbul
34764
Turkey (Türkiye)
Ege University Medical of Faculty, Department of Gastroenterology
Izmir
35100
Turkey (Türkiye)
Acibadem Mehmet Ali Aydinlar University
Küçükçekmece
34303
Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon
61080
Turkey (Türkiye)
NHS Greater Glasgow and Clyde - Gartnavel General Hospital
Glasgow
G12 0YN
United Kingdom
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
Grahame Hayton Unit
London
E1 1BB
United Kingdom
Kings College Hospital
London
SE5 9RF
United Kingdom
FG001
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
FG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
FG00027 subjects
FG0018 subjects
FG00219 subjects
COMPLETED
FG00026 subjects
FG0018 subjects
FG00217 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0022 subjects
Consolidation Phase (CP):CP Week 1 to 12
Type
Comment
Milestone Data
STARTED
FG00025 subjects1 participant discontinued JNJ-3989 treatment due to treatment failure/relapse and moved directly to FU phase without CP.
FG0017 subjects1 participant discontinued JNJ-3989 treatment due to treatment failure/relapse and moved directly to FU phase without CP.
FG00217 subjects
COMPLETED
FG00025 subjects
FG0017 subjects
FG00217 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
Follow-up (FU) Phase: FU Week 1 to 48
Type
Comment
Milestone Data
STARTED
FG00026 subjects1 participant moved directly to FU phase without CP.
FG0018 subjects1 participant moved directly to FU phase without CP.
FG00217 subjects
COMPLETED
FG00026 subjects
FG0016 subjects
FG00217 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: JNJ-3989 200 mg + JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP) received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
BG001
Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
BG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG0018
BG00219
BG00354
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
BG00035.6± 9.95
BG00127.3± 9.95
BG00233.6± 11.15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
CANADA
Title
Measurements
BG0003
BG0010
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 With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment
Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \
Per protocol analysis set: all randomized/enrolled participants who received at least 1 dose of CP study intervention and did not had any of the selected major protocol deviations that might affect the assessment of efficacy in terms of the primary endpoint at 24 weeks after stopping all study interventions of the CP.
Posted
Number
percentage of participants
At follow-up (FU) phase Week 24
ID
Title
Description
OG000
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
OG001
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
OG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0018
OG00217
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0020(0 to 0)
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment.
Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Posted
Count of Participants
Participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Number of participants with TESAEs were reported. was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Posted
Count of Participants
Participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
Secondary
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Clinical laboratory test parameters were Hematology: absolute lymphocyte count, absolute neutrophil count (ANC), hemoglobin, Neutrophils Band Form, Neutrophils segmented, white blood cells (WBC) decreased, ; Chemistry: alanine aminotransferase (ALT) & serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT), cholesterol (fasting), creatinine Kinase, creatinine, GFR from Creatinine Adjusted for BSA, GFR from Cystatin C Adjusted for BSA, low-density lipoprotein (LDL), triglycerides (fasting); Urinalysis: glycosuria. DAIDS toxicity grades: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Number of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure.
Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories.
Posted
Count of Participants
Participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
Secondary
Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)
Number of participants with worst treatment-emergent abnormality in ECG were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. ECG parameters included heart rate (HR; abnormally low, HR <45 beats per minute (bpm) and (abnormally high HR>=120 bpm; PR interval abnormally high >220 milliseconds (ms): QRS interval abnormally high >=120 ms; QT corrected (Fridericia QTcF) categories; borderline prolonged QTc interval <450 to <=480 ms), prolonged QTc interval <480 to <=500 ms) and pathologically prolonged QTc interval >500 ms).
Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Posted
Count of Participants
Participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
Secondary
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Number of participants with worst treatment-emergent abnormalities in vital signs were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. Abnormalities in vital signs included abnormal pulse rate (PR); abnormally low, <=45 bpm and abnormally high >=120 bpm; diastolic blood pressure (DBP) abnormally low <=50 mmHg, systolic blood pressure (SBP) abnormally low <=90 mmHg. Additionally, abnormal low SBP and DBP were <=50 mmHg and <+90 mmHg. Only those categories in which at least one participant had data were reported.
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
Posted
Count of Participants
Participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
Secondary
Number of Participants With Clinically Important Abnormalities in Physical Examination
Number of participants with clinically important treatment-emergent abnormalities in physical examination were reported.
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
Posted
Count of Participants
Participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)
Percentage of participants who reached HBsAg <10 IU/mL at the end induction phase were reported.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here, "n"(number analyzed) signifies participants who were evaluable at specified timepoints. Data for this outcome measure were planned to be collected and analyzed for IP only.
Posted
Number
percentage of participants
At IP Week 36 and EOI; anytime up to IP Week 52 for Cohort 1; up to IP Week 36 for Cohort 2
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a
In IP, participants (enrolled prior to PA5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA5.
OG002
Secondary
Time to Achieve First Occurrence of HBsAg <10 IU/mL
Time to achieve first occurrence of HBsAg <10 IU/mL were reported. Time to HBsAg <10 IU/mL was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg <10 IU/mL. Kaplan-Meier method was used for the estimation.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.
Posted
Median
90% Confidence Interval
weeks
From Baseline (Day 1 of IP) up to Follow-up phase Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
ID
Title
Description
OG000
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
Secondary
Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase
Percentage of participants meeting the protocol-defined NA treatment completion criteria at end of consolidation were reported. NA treatment completion criteria at CP Week 12 was defined as HBsAg <10 IU/mL; HBeAg-negative; HBV DNA <20 IU/mL, (that is, LLOQ); alanine aminotransferase(ALT) <3*ULN.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG001
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
Secondary
FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
Percentage of participants with HBsAg seroclearance 48 weeks after stopping all study interventions at the consolidation phase and without restarting NA treatment during follow up phase were reported. HBsAg seroclearance was defined as (quantitative) HBsAg < LLOQ (HBsAg 0.05 IU/mL).
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Posted
Number
percentage of participants
FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
Percentage of participants with HBV DNA \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Posted
Number
percentage of participants
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase
Number of participants with off-treatment virologic HBV flares were reported. Virologic flare was defined as confirmed HBV DNA >peak threshold (lowest peak to qualify as virologic flare was HBV DNA >200 IU/mL) in participants who were off-treatment and had HBV DNA \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Posted
Count of Participants
Participants
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase
Number of participants with off-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA).
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Posted
Count of Participants
Participants
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase
Number of participants with on-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. On-treatment was defined as the time period during which the participant received any of the study drugs.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.
Posted
Count of Participants
Participants
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase
Clinical flares occurred either when a virologic flare (confirmed HBV DNA >peak threshold) & biochemical flare (ALT and/or AST >=3*ULN & >=3*nadir [lowest value observed during off-treatment period up to time point of meeting the flare criteria]) overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. The HBV DNA thresholds were: 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that criteria was fulfilled at 2 or more consecutive time points or at last observed time point. Off-treatment was defined as time period after stopping all study drugs (including NA). The start date of a clinical flare was minimum start date of virologic flare and biochemical flare.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Posted
Count of Participants
Participants
FU phase: FU Week 1 up to FU Week 48(up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase
Percentage of participants who required NA re-treatment during follow-up phase were reported. A 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.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Posted
Number
percentage of participants
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per Definition 1) were reported. Sustained HBsAg response (definition 1) was defined as: For participants with FU Week 48 data: participants who had a >1 log10 decline from baseline in HBsAg and HBsAg <000 IU/mL at FU Week 48. For participants without FU Week 48 data: participants who had a HBsAg decline from baseline of >2 log10 at FU Week 24 or >1.5 log10 at FU Week 36 (most recent value used) and had HBsAg <1000 IU/mL at the last available timepoint.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per Definition 2) were reported. Sustained HBsAg response (per Definition 2) was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was <0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was <0.2.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response (per definition 3) were reported. Sustained HBsAg response (per Definition 3) was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was <0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was <0.2 and had an HBsAg <1000 IU/mL at the last available timepoint.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Percentage of participants with sustained (reduction) HBsAg response per Definition 4 were reported. Sustained HBsAg response (per Definition 4) was defined as stable level, decreasing level, and increasing level. Stable level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was within 0.2 log10. Decreasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was less than -0.2 log10. Increasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was more than 0.2 log10.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Posted
Number
percentage of participants
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48
Percentage of Participants with HBsAg Seroclearance were reported. HBsAg seroclearance was defined as (quantitative) HBsAg level \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48
Percentage of participants with HBeAg seroclearance were reported. HBeAg seroclearance was defined as (quantitative) HBeAg levels \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Posted
Number
percentage of participants
At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
Percentage of Participants With HBsAg Seroconversion
Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg <LLOQ [<0.05 IU/mL]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies [quantitative] <LLOQ [<5 milli-international units per milliliter (mIU/mL)] and a post-baseline assessment >=LLOQ [>=5 mIU/mL]).
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies participants evaluable at specified timepoints. Also, n=0 signifies that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Posted
Number
percentage of participants
IP Week 24; CP: Week 12, FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Percentage of Participants With HBeAg Seroconversion
Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as [quantitative] HBeAg \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analyzed) signifies participants evaluable at specified timepoints. Data were planned to be collected and analyzed for CP and FU phase only. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Posted
Number
percentage of participants
CP: Week 12; FU phase: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG001
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
Change From Baseline Over Time in HBsAg Levels
Change from baseline over time in HBsAg levels at specified timepoints were reported
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Change From Baseline Over Time in HBeAg Levels
Change from baseline over time in HBsAg levels at specified timepoints were reported.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Change From Baseline Over Time in HBV DNA Levels
Change from baseline over time in HBV DNA Levels at Specified Timepoints were reported.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Time to Achieve First HBsAg Seroclearance
Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this endpoint. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
Posted
Median
90% Confidence Interval
weeks
From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
ID
Title
Description
OG000
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
Secondary
Time to Achieve First HBeAg Seroclearance
Time to achieve first occurrence of HBeAg seroclearance (HBeAg \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
Posted
Median
90% Confidence Interval
weeks
From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
ID
Title
Description
OG000
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
Secondary
Time to Achieve First HBV DNA <LLOQ
Time to achieve first occurrence of HBV DNA < LLOQ (<20 IU/mL) were reported. Time to first occurrence of the HBV DNA < LLOQ was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA < LLOQ.
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
Posted
Median
90% Confidence Interval
weeks
From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
ID
Title
Description
OG000
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg <10 IU/mL, HBeAg negative, and HBV DNA \
Secondary
Percentage of Participants With HBeAg Levels Below Different Cut-offs
Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were : \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Percentage of Participants With HBsAg Levels Below Different Cut-offs
Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number of participants analyzed) signifies participants analyzed at specified categories. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
Secondary
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level < LLOQ (<20 IU/mL) or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level \
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Secondary
Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up
Percentage of participants who reached HBV DNA undetectability after re-start of NA treatment during follow-up were reported. Undetectability of HBV DNA was defined as HBV DNA\
Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N=0 signifies that data could not be analyzed due to insufficient number of participants with events.
Posted
Number
percentage of participants
FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Secondary
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Cmax of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Noncompartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules
Pharmacokinetics analysis set (PK): included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this outcome measure was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Posted
Mean
Standard Deviation
nanogram per milliliters (ng/mL)
IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8
ID
Title
Description
OG000
Induction Phase
Prior PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD for >=36-weeks to <=52-weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week CP and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 mcg SC injection QW. In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (either tenofovir disoproxil 250 mg or 25 mg tenofovir alafenamide) tablet orally QD for 36 weeks in IP. Post PA 5, participant not reached IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit.
Secondary
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules.
Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Posted
Median
Full Range
hour
IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8
ID
Title
Description
OG000
Induction Phase
Prior PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD for >=36-weeks to <=52-weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week CP and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 mcg SC injection QW. In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (either tenofovir disoproxil 250 mg or 25 mg tenofovir alafenamide) tablet orally QD for 36 weeks in IP. Post PA 5, participant not reached IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit.
Secondary
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Plasma concentration 24 hours after administration (C24h) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted to analyze C24h of JNJ-73763989 and its molecules.
Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Posted
Mean
Standard Deviation
ng/mL
IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit
ID
Title
Description
OG000
Induction Phase
Prior PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD for >=36-weeks to <=52-weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week CP and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 mcg SC injection QW. In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (either tenofovir disoproxil 250 mg or 25 mg tenofovir alafenamide) tablet orally QD for 36 weeks in IP. Post PA 5, participant not reached IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit.
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (molecules:JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted toanalyze AUC0 to 24h of JNJ-73763989 and its molecules.
Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Posted
Mean
Standard Deviation
nanograms*hour per milliliters (ng*h/mL)
IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit
ID
Title
Description
OG000
Induction Phase
Prior PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD for >=36-weeks to <=52-weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week CP and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 mcg SC injection QW. In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (either tenofovir disoproxil 250 mg or 25 mg tenofovir alafenamide) tablet orally QD for 36 weeks in IP. Post PA 5, participant not reached IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit.
Time Frame
IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Description
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.
0
27
0
27
19
27
EG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
0
8
0
8
8
8
EG002
IP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
0
25
0
25
21
25
EG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
0
7
0
7
7
7
EG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
0
26
0
26
15
26
EG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU W2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
0
8
0
8
5
8
EG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
0
17
1
17
11
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG0030 affected25 at risk
EG004
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG0031 affected25 at risk
EG0040 affected7 at risk
EG0050 affected17 at risk
EG0060 affected26 at risk
EG0070 affected8 at risk
EG0081 affected17 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Cataract
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Conjunctival Hyperaemia
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Myopia
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Visual Impairment
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0022 affected19 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0022 affected19 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0021 affected19 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0022 affected19 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0004 affected27 at risk
EG0013 affected8 at risk
EG0022 affected19 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0021 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Asthenia
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Chills
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Fatigue
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0012 affected8 at risk
EG0022 affected19 at risk
EG003
Hyperthermia
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Injection Site Bruising
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Injection Site Erythema
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0021 affected19 at risk
EG003
Injection Site Pain
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Injection Site Rash
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Injection Site Reaction
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Injury Associated with Device
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Pain
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0011 affected8 at risk
EG0021 affected19 at risk
EG003
Temperature Intolerance
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Food Allergy
Immune system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Mite Allergy
Immune system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0012 affected8 at risk
EG0020 affected19 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Aspergilloma
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Carbuncle
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0012 affected8 at risk
EG0024 affected19 at risk
EG003
Hepatitis B
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Lower Respiratory Tract Infection Viral
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0022 affected19 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Skin Wound
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0008 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Body Temperature Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Glucose Urine Present
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Liver Scan Abnormal
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Ultrasound Liver Abnormal
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Vitamin B12 Deficiency
Metabolism and nutrition disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected27 at risk
EG0011 affected8 at risk
EG0022 affected19 at risk
EG003
Limb Mass
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0021 affected19 at risk
EG003
Haemangioma of Liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Amnestic Disorder
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0005 affected27 at risk
EG0013 affected8 at risk
EG0022 affected19 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Anxiety Disorder
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0021 affected19 at risk
EG003
Apathy
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Allergic Sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0022 affected19 at risk
EG003
Dry Throat
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected27 at risk
EG0011 affected8 at risk
EG0020 affected19 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0021 affected19 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected8 at risk
EG0020 affected19 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 withhold such publication for up to an additional 60 days.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
OG00325
OG0047
OG00517
OG00626
OG0078
OG00817
Title
Denominators
Categories
Title
Measurements
OG00022
OG0018
OG00215
OG00322
OG0047
OG00513
OG00617
OG0075
OG00811
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
OG00325
OG0047
OG00517
OG00626
OG0078
OG00817
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG001
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3
ParticipantsOG00026
ParticipantsOG0018
ParticipantsOG00219
ParticipantsOG003
Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3
ParticipantsOG00026
ParticipantsOG0018
ParticipantsOG00219
ParticipantsOG003
Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4
ParticipantsOG00026
ParticipantsOG0018
ParticipantsOG00219
ParticipantsOG003
Chemistry: LDL (Fasting): High: Grade 3
ParticipantsOG00026
ParticipantsOG0018
ParticipantsOG00219
ParticipantsOG00325
Chemistry: Triglycerides (Fasting): High: Grade 3
ParticipantsOG00026
ParticipantsOG0018
ParticipantsOG00219
ParticipantsOG003
Urinalysis: Glycosuria: Grade 3
ParticipantsOG00017
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG00313
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
OG00325
OG0047
OG00517
OG00626
OG0078
OG00817
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0018
OG00219
OG00325
OG0047
OG00517
OG00626
OG0078
OG00817
Title
Denominators
Categories
DBP: High:
Title
Measurements
OG0003
OG0011
OG0021
OG0031
OG0040
OG0051
OG0061
OG0071
OG0080
SBP: Low
Title
Measurements
OG0000
OG0011
OG0020
OG003
SBP: High
Title
Measurements
OG0002
OG0011
OG0023
OG003
Pulse rate: High
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
OG00325
OG0047
OG00517
OG00626
OG0078
OG00817
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
Units
Counts
Participants
OG00026
OG0017
OG00219
Title
Denominators
Categories
IP Week 36
ParticipantsOG00013
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG0000(0 to 0)
OG00210(1 to 11)
End of Induction phase
ParticipantsOG00026
ParticipantsOG0017
ParticipantsOG00219
Title
Measurements
OG000
OG001
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
OG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
Title
Denominators
Categories
Title
Measurements
OG00048.1(NA to NA)NA indicates that upper limit and lower limit of CI was not estimable due to insufficient number of participants with events.
OG00184.3(2.1 to NA)NA indicates that upper limit of 90% CI was not estimable due to insufficient number of participants with events.
OG00248.3(36.1 to NA)NA indicates that upper limit of 90% CI was not estimable due to insufficient number of participants with events.
OG002
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
Units
Counts
Participants
OG00025
OG0017
OG00217
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0025.9(0 to 0)
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0016
OG00217
Title
Denominators
Categories
Title
Measurements
OG00011.5(1 to 12)
OG00116.7(1 to 17)
OG00211.8(1 to 12)
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG0000
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG0020(0 to 0)
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG0000
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG0020
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG0000
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG0020
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0018
OG00217
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0022
OG001
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG0000
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG0020
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG0000
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG0020(0 to 0)
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0017
OG00217
Title
Denominators
Categories
Title
Measurements
OG00053.85(1 to 56)
OG00157.1(1 to 58)
OG00270.6(1 to 80)
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0017
OG00217
Title
Denominators
Categories
Title
Measurements
OG00065.4(1 to 67)
OG00142.9(1 to 50)
OG00270.6(1 to 71)
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0017
OG00217
Title
Denominators
Categories
Title
Measurements
OG00042.3(1 to 43)
OG00128.6(1 to 30)
OG00252.9(1 to 53)
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0017
OG00217
Title
Denominators
Categories
Stable: within +/-0.2 log10 IU/mL
Title
Measurements
OG0000(0 to 0)
OG00114.3(0 to 15)
OG00211.8(0 to 12)
Decreased: <0.2 log10 IU/mL
Title
Measurements
OG00019.2(0 to 20)
OG00114.3(0 to 15)
OG00217.6(0 to 18)
Increased: > +0.2 log10 IU/mL
Title
Measurements
OG00076.9(0 to 80)
OG00171.4(0 to 72)
OG00270.6(0 to 72)
Missing
Title
Measurements
OG0003.9
OG0010
OG0020
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00026
OG0016
OG00217
Title
Denominators
Categories
Title
Measurements
OG00011.5(1 to 12)
OG00116.7(1 to 17)
OG00211.8(1 to 90)
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00025
OG0016
OG00217
Title
Denominators
Categories
Title
Measurements
OG00028.0(1 to 30)
OG00133.3(1 to 40)
OG00217.6(1 to 18)
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00025
OG0017
OG00215
OG00324
OG0046
OG00515
OG00625
OG0077
OG00815
Title
Denominators
Categories
IP: Week 24
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000
OG0010
OG0020
CP: Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00324
FU phase Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG002
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG004
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG005
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00021
OG0016
OG00211
OG00322
OG0047
OG00511
Title
Denominators
Categories
CP: Week 12
ParticipantsOG00021
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000
OG00116.7
OG0029.1
FU phase: week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00322
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00025
OG0017
OG00215
OG00325
OG0047
OG00517
OG00626
OG0076
OG00817
Title
Denominators
Categories
IP: Week 36
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000-2.78± 0.198
OG001-3.35± 0.417
OG002-2.73± 0.150
CP: Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
FU phase: Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00024
OG0017
OG00215
OG00324
OG0047
OG00517
OG00625
OG0076
OG00817
Title
Denominators
Categories
IP: Week 36
ParticipantsOG00024
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000-1.78± 0.103
OG001-1.77± 0.151
OG002-1.49± 0.141
CP: Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00324
FU phase: Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00025
OG0017
OG00215
OG00325
OG0046
OG00517
OG00626
OG0076
OG00817
Title
Denominators
Categories
IP: Week 36
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000-6.36± 0.218
OG001-6.08± 0.202
OG002-6.26± 0.231
CP: Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
FU phase: Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
OG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA indicates that median \[90% CI\] data were not estimable due to insufficient number of participants with events.
OG001NA(6.1 to NA)NA indicates that median \[90% CI\] data were not estimable due to insufficient number of participants with events.
OG002NA(NA to NA)NA indicates that median \[90% CI\] data were not estimable due to insufficient number of participants with events.
OG001
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
OG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
Title
Denominators
Categories
Title
Measurements
OG000112(96.1 to NA)NA indicates that upper interval of CI data were not estimable due to insufficient number of participants with events.
OG001100.3(48.0 to NA)NA indicates that upper interval of CI data were not estimable due to insufficient number of participants with events.
OG002NA(59.1 to NA)NA indicates that Median and upper interval of CI data were not estimable due to insufficient number of participants with events.
OG001
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for >=36 to <=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
OG002
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
Title
Denominators
Categories
Title
Measurements
OG00035.9(28.1 to 52.1)
OG00153.3(12.1 to NA)NA indicates that lower interval of CI data were not estimable due to insufficient number of participants with events.
OG00238.1(24.1 to 50.1)
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00024
OG0017
OG00215
OG00324
OG0047
OG00517
OG00625
OG0076
OG00817
Title
Denominators
Categories
IP Week 36: <0.11 IU/mL
ParticipantsOG00024
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00012.5
OG0010
OG0020
IP Week 36: <1 IU/mL
ParticipantsOG00024
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36: <10 IU/mL
ParticipantsOG00024
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36: <100 IU/mL
ParticipantsOG00024
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
CP Week 12: <0.11 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00324
CP Week 12: <1 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00324
CP Week 12: <10 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00324
CP Week 12: <100 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00323
FU Week 48: <0.11 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <1 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <10 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <100IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00025
OG0017
OG00215
OG00325
OG0047
OG00517
OG00626
OG0076
OG00817
Title
Denominators
Categories
IP Week 36: <0.05 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000
OG00114.3
OG0020
IP Week 36: <1 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36: <10 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36: <100 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36: <1000 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
CP Week 12: <0.05 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12: <1 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12: <10 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12: <100 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12: <1000 IU0/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
FU Week 48: <0.05 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <1 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <10 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <100 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48: <1000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00025
OG0017
OG00215
OG00325
OG0046
OG00517
OG00626
OG0076
OG00817
Title
Denominators
Categories
IP Week 36:<LLOQ target detected and not detected
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00052.0
OG00128.6
OG00240.0
IP Week 36:<LLOQ for target not detected
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<LLOQ for target detected
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<60 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<100 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<200 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<1000 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<2000 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
IP Week 36:<20000 IU/mL
ParticipantsOG00025
ParticipantsOG0017
ParticipantsOG00215
ParticipantsOG0030
CP Week 12:<LLOQ: target detected and not detected
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
CP Week 12:<LLOQ for target not detected
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<LLOQ for target detected
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<60 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<100 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<200 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<1000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<2000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
CP Week 12:<20000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
FU Week 48:<LLOQ target detected and not detected
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
FU Week 48: <LLOQ for target not detected
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<LLOQ for target detected
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<60 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<100 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<200 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<1000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<2000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FU Week 48:<20000 IU/mL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for >=36-weeks to <=52-weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
OG002
IP: Cohort 2 : JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
OG004
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
OG005
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG007
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
OG008
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
OG00325
OG0047
OG00517
OG00626
OG0077
OG00817
Title
Denominators
Categories
Title
Measurements
OG0003.7
OG00112.5
OG0020
OG0030
OG0040
OG0050
OG0060
OG00750.0
OG0080
OG002
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
Units
Counts
Participants
OG00027
OG0018
OG00219
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG001
Consolidation Phase
After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
JNJ-73763976
Title
Measurements
OG0001376± 1266
OG001700± 227
JNJ-73763924
Title
Measurements
OG000279± 308
OG001135± 39.9
OG001
Consolidation Phase
After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
JNJ-73763976
Title
Measurements
OG0005.53(2.50 to 6.00)
OG0013.99(2.98 to 6.00)
JNJ-73763924
Title
Measurements
OG0004.00(0.50 to 5.73)
OG0012.99(1.00 to 4.00)
OG001
Consolidation Phase
After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.
Units
Counts
Participants
OG0007
OG0016
Title
Denominators
Categories
JNJ-73763976
Title
Measurements
OG000315± 213
OG001381± 155
JNJ-73763924
Title
Measurements
OG00036.9± 27.9
OG00154.7± 25.0
OG001
Consolidation Phase
After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.