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| ID | Type | Description | Link |
|---|---|---|---|
| 73763989PAHPB2008 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-005132-33 | EudraCT Number |
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The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
JNJ-73763989 (JNJ-3989) is a small interfering ribonucleic acid (siRNA) targeting all hepatitis B virus (HBV) messenger ribonucleic acid (mRNAs). The programmed cell death protein receptor-1 (PD-1) inhibitor aims at preventing the interaction of PD-1 with its ligands. The purpose of this study to determine whether at least one of the combination regimens of JNJ-3989 + PD-1 inhibitor + Nucleos(t)ide analog (NA) is more efficacious than JNJ-3989 + NA treatment. This study will be conducted in 3 periods: screening period, treatment period and follow-up (FU) period. Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. Total duration of individual participation will be up to 78 weeks (including screening period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA) | Experimental | Participants will receive JNJ-73763989 subcutaneous (SC) injections and single dose of programmed cell death protein receptor-1 (PD-1) inhibitor as intravenous (IV) infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, tenofovir alafenamide [TAF] or entecavir [ETV]). |
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| Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA | Experimental | Participants will receive JNJ-73763989 SC injections and multiple doses of PD-1 inhibitor as IV infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, TAF or ETV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-73763989 | Drug | JNJ-73763989 will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 | Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters [IU/mL]). | At FU Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada | ||
| Fakultni nemocnice Hradec Kralove |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42320551 | Derived | Asselah T, Fung SK, Akhan S, Chuang WL, Buti M, Brunetto M, Agarwal K, Diba C, Jezorwski J, Berger V, T'jollyn H, Tsou WI, Kakuda TN, Lonjon-Domanec I, Nalpas C, Guinard-Azadian C, Verbinnen T, Lathouwers E, De Creus A, Lenz O, Biermer M. No impact of low-dose nivolumab addition to JNJ-73763989 on HBsAg declines in chronic hepatitis B: the OCTOPUS-1 study. Clin Gastroenterol Hepatol. 2026 Jun 19:S1542-3565(26)00471-4. doi: 10.1016/j.cgh.2026.06.018. Online ahead of print. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + Nucleos(t)Ide Analog (NA) | In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 milligrams per kilogram (mg/kg) as intravenous (IV) infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to follow up (FU) Week 48 (up to Week 72). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention Phase: Week 0 to Week 24 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2023 | Dec 11, 2024 |
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| PD-1 inhibitor | Drug | PD-1 inhibitor will be administered as IV infusion. |
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| Tenofovir Disoproxil | Drug | Tenofovir disoproxil film-coated tablets will be administered orally. |
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| Tenofovir Alafenamide | Drug | TAF film-coated tablets will be administered orally. |
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| Entecavir | Drug | ETV film-coated tablets will be administered orally. |
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| IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With TEAEs by Severity | Number of participants with TEAEs by severity were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With Immune Related TEAEs | Number of participants with immune related TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to [<=] 45 beats per minute [bpm], abnormally high: greater than or equal to [>=] 120 bpm; diastolic blood pressure [BP]: abnormally low: <=50 millimeters of mercury [mmHg], mild: >90 to <100 mmHg, moderate: >=100 to <110 mmHg, and severe: >=110 mmHg; systolic BP: abnormally low: <=90 mmHg, mild: >140 to <160 mmHg, moderate: >=160 to <180 mmHg, and severe: >=180 mmHg) were reported. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | Number of participants with abnormalities in 12-lead ECGs: heart rate (abnormally low: <45 beats per minute [bpm], abnormally high: greater than or equal [>=] 120 bpm), PR interval (abnormally high: greater than [>] 220 millisecond [msec]), QRS interval (abnormally high: >=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450< QTc <=480 msec; Prolonged QT: 480 < QTc <=500; Pathologically prolonged QT: QTc >500) were reported. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations were reported. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | Percentage of participants with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | Number of participants with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein [HDL] cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | Number of participants with abnormalities in clinical laboratory parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | Change from baseline in HBsAg levels were reported. International units per milliliters=IU/mL. End of Study Intervention (EOSI) was the last post-baseline visit in study intervention period. End of study (EOS) was the last visit in the study. | IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and End of Study Intervention (EOSI; Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | Percentage of participants with change in HBsAg levels below/above different cut-offs (<0.05 IU/mL, <1 U/mL, <10 IU/mL, <100 IU/mL , <1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. | IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| Percentage of Participants With HBsAg Seroclearance | Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level \ | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Percentage of Participants With HBsAg Seroconversion | Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ). | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Time to Achieve HBsAg Seroclearance | Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level \ | Week 0 up to FU Week 48 (up to Week 72) |
| Time to Achieve HBsAg Seroconversion | Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ). | Week 0 up to FU Week 48 (up to Week 72) |
| Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. | IP: Baseline, Weeks 2, 4, 8, 12, 16, 20 and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | Percentage of participants with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: \ | IP: Baseline, Weeks 2, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | Percentage of participants with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: \ | IP: Baseline, Weeks 2, 4, 8, 12, 20, and EOSI (Week 24); FU Phase: FU Weeks 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| Percentage of Participants With Virologic Breakthrough | Percentage of participants with virologic breakthrough (confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir in participants who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level below LLOQ) were reported. | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| Hradec Králové |
| 500 05 |
| Czechia |
| IKEM | Prague | 140 21 | Czechia |
| Hopital Beaujon | Clichy | 92110 | France |
| Hopital Saint Joseph | Marseille | 13008 | France |
| Chu Rennes Hopital Pontchaillou | Rennes | 35000 | France |
| CHRU Nancy Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano | Milan | 20122 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56124 | Italy |
| Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma | Rome | 00161 | Italy |
| Hosp Univ Vall D Hebron | Barcelona | 8035 | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Madrid | 28222 | Spain |
| Hosp. Montecelo | Pontevedra | 36071 | Spain |
| Hosp. Gral. Univ. Valencia | Valencia | 46014 | Spain |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| E-DA Hospital | Kaohsiung City | 824 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| Hacettepe University Medical Faculty | Ankara | 06230 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35040 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41001 | Turkey (Türkiye) |
| Karadeniz Teknik University Medical Faculty | Trabzon | 61080 | Turkey (Türkiye) |
| Glasgow Royal Infirmary | Glasgow | G31 2ER | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Imperial College London and Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| FG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
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| NOT COMPLETED |
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| FU Phase: FU Week 1 to FU Week 48 |
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| ID | Title | Description |
|---|---|---|
| BG000 | JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
| BG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| AgeContinuous | Mean | Standard Deviation | years |
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| 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 | |||||||||||||||||||||||
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| Primary | Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 | Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters [IU/mL]). | Full analysis set (FAS) included all participants who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA. | Posted | Number | Percentage of participants | At FU Week 24 |
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| Secondary | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest | An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. | Posted | Number | Percentage of participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With TEAEs by Severity | Number of participants with TEAEs by severity were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With Immune Related TEAEs | Number of participants with immune related TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to [<=] 45 beats per minute [bpm], abnormally high: greater than or equal to [>=] 120 bpm; diastolic blood pressure [BP]: abnormally low: <=50 millimeters of mercury [mmHg], mild: >90 to <100 mmHg, moderate: >=100 to <110 mmHg, and severe: >=110 mmHg; systolic BP: abnormally low: <=90 mmHg, mild: >140 to <160 mmHg, moderate: >=160 to <180 mmHg, and severe: >=180 mmHg) were reported. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) | Number of participants with abnormalities in 12-lead ECGs: heart rate (abnormally low: <45 beats per minute [bpm], abnormally high: greater than or equal [>=] 120 bpm), PR interval (abnormally high: greater than [>] 220 millisecond [msec]), QRS interval (abnormally high: >=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450< QTc <=480 msec; Prolonged QT: 480 < QTc <=500; Pathologically prolonged QT: QTc >500) were reported. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) refers to number of participants evaluable at specified parameter. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations were reported. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology | Percentage of participants with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter. | Posted | Number | Percentage of participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry | Number of participants with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein [HDL] cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis | Number of participants with abnormalities in clinical laboratory parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, N (number of participants analyzed) signifies number of participants analyzed for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified category. | Posted | Count of Participants | Participants | IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
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| Secondary | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels | Change from baseline in HBsAg levels were reported. International units per milliliters=IU/mL. End of Study Intervention (EOSI) was the last post-baseline visit in study intervention period. End of study (EOS) was the last visit in the study. | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Mean | Standard Deviation | log10 IU/mL | IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and End of Study Intervention (EOSI; Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time | Percentage of participants with change in HBsAg levels below/above different cut-offs (<0.05 IU/mL, <1 U/mL, <10 IU/mL, <100 IU/mL , <1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Number | Percentage of participants | IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Seroclearance | Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level \ | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. | Posted | Number | Percentage of participants | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Seroconversion | Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ). | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified categories. | Posted | Number | Percentage of participants | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Achieve HBsAg Seroclearance | Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level \ | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. N=0 signifies that data could not be collected and analyzed as no participant had event. | Posted | Median | Full Range | Days | Week 0 up to FU Week 48 (up to Week 72) |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Achieve HBsAg Seroconversion | Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ). | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, N=0 signifies that data could not be collected and analyzed as no participant had event. | Posted | Median | Full Range | Days | Week 0 up to FU Week 48 (up to Week 72) |
| ||||||||||||||||||||||||||||||
| Secondary | Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time | HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Mean | Standard Deviation | log10 IU/mL | IP: Baseline, Weeks 2, 4, 8, 12, 16, 20 and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time | Percentage of participants with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: \ | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint. | Posted | Number | Percentage of participants | IP: Baseline, Weeks 2, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time | Percentage of participants with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: \ | FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint. Here, n=0 signifies no participant was analyzed at specified timepoint. | Posted | Number | Percentage of participants | IP: Baseline, Weeks 2, 4, 8, 12, 20, and EOSI (Week 24); FU Phase: FU Weeks 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Breakthrough | Percentage of participants with virologic breakthrough (confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir in participants who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level below LLOQ) were reported. | FAS included all participants who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA. | Posted | Number | Percentage of participants | IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48 |
|
IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IP: JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA | In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as intravenous (IV) infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. | 0 | 18 | 0 | 18 | 6 | 18 |
| EG001 | IP: JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. | 0 | 19 | 0 | 19 | 12 | 19 |
| EG002 | FU: JNJ-3989 + Nivolumab (1 Infusion) + NA | After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). | 0 | 18 | 0 | 18 | 8 | 18 |
| EG003 | FU: JNJ-3989 + Nivolumab (3 Infusions) + NA | After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). | 0 | 19 | 0 | 19 | 8 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ocular Hyperaemia | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Tenderness | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Laryngopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cervical Radiculopathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Renal Cyst | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Intermenstrual Bleeding | Reproductive system and breast disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
Per protocol amendment 2 (28 Mar 2023), due to difficulties in recruitment, further participants enrollment was stopped. Hence, pharmacokinetic assessments were not performed due to change in planned analysis.
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 to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2024 | Dec 11, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D000068698 | Tenofovir |
| C442442 | tenofovir alafenamide |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| FRANCE |
|
| ITALY |
|
| SPAIN |
|
| TAIWAN |
|
| TURKEY |
|
| UNITED KINGDOM |
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA |
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
|
|
| OG001 |
| JNJ-3989 + Nivolumab (3 Infusions) + NA |
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
|
|
|
|
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
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In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
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| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
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| OG001 | JNJ-3989 + Nivolumab (3 Infusions) + NA | In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
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In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72). |
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