An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

Browse trials for

• Hepatitis A 2,709
• Hepatitis B 1,656
• Hepatitis B, Chronic 942
• Hepatitis 3,380

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA)

  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 \[ETV\]).

  Drug: JNJ-73763989 · Drug: PD-1 inhibitor · Drug: Tenofovir Disoproxil · Drug: Tenofovir Alafenamide · Drug: Entecavir

• Experimental
  Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

  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).

  Drug: JNJ-73763989 · Drug: PD-1 inhibitor · Drug: Tenofovir Disoproxil · Drug: Tenofovir Alafenamide · Drug: Entecavir

Interventions

• DrugJNJ-73763989

  JNJ-73763989 will be administered subcutaneously.

  Also known as: JNJ-3989

• DrugPD-1 inhibitor

  PD-1 inhibitor will be administered as IV infusion.

• DrugTenofovir Disoproxil

  Tenofovir disoproxil film-coated tablets will be administered orally.

• DrugTenofovir Alafenamide

  TAF film-coated tablets will be administered orally.

• DrugEntecavir

  ETV film-coated tablets will be administered orally.

Primary outcomes

1. 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 \[IU/mL\]).

   Time frame: At FU Week 24

Secondary outcomes

1. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

2. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

3. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

4. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

5. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

6. Number of Participants With Abnormalities in Physical Examinations

   Number of participants with abnormalities in physical examinations were reported.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

7. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

8. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

9. 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.

   Time frame: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

10. 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.

    Time frame: 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)

11. 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.

    Time frame: 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)

12. Percentage of Participants With HBsAg Seroclearance

    Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level \<lower limit of quantification (LLOQ) (0.05 IU/mL).

    Time frame: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48

13. 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).

    Time frame: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48

14. Time to Achieve HBsAg Seroclearance

    Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level \<LLOQ (0.05 IU/mL).

    Time frame: Week 0 up to FU Week 48 (up to Week 72)

15. 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).

    Time frame: Week 0 up to FU Week 48 (up to Week 72)

16. 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.

    Time frame: 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)

17. 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: \<LLOQ target detected (TD): that is, traces of HBV DNA were detected/found but were too low to be quantified; \<LLOQ target not detected (TND): that is, no traces of HBV DNA were detected/found. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. The LLOQ for HBV DNA was 20 IU/mL. As indicated in the data table, the sum of percentage values of each sub-categories within the specific timepoints "IP: Week 2" and "FU Phase: Week 4", shows a slight deviation from 100% due to rounding.

    Time frame: 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)

18. 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: \<LLOQ (0.11 IU/mL). EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

    Time frame: 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)

19. 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.

    Time frame: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48

Baseline characteristics

Study documents

• Study protocol · Jun 30, 2023
• Statistical analysis plan · Jun 10, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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