Phase 2
Completed N=54
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
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT04439539 ↗
Enrolled (actual)
54
Serious AEs
0.7%
Results posted
Sep 2024
Primary outcomePrimary: 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 — 0; 0; 0 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
22; 8; 15; 22; 7; 13 | — |
| SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs |
3; 1; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Important Abnormalities in Physical Examination |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI) |
0; 10; 15.4; 37.5; 10.5 | — |
| SECONDARY Time to Achieve First Occurrence of HBsAg <10 IU/mL |
48.1; 84.3; 48.3 | — |
| SECONDARY Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase |
0; 0; 5.9 | — |
| 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 |
11.5; 16.7; 11.8 | — |
| 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 |
— | — |
| SECONDARY FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase |
— | — |
| SECONDARY FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase |
— | — |
| SECONDARY FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase |
2; 0; 2 | — |
| SECONDARY FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase |
— | — |
| SECONDARY FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase |
— | — |
| SECONDARY FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48 |
53.85; 57.1; 70.6 | — |
| SECONDARY Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48 |
65.4; 42.9; 70.6 | — |
| SECONDARY Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48 |
42.3; 28.6; 52.9 | — |
| SECONDARY Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48 |
0; 14.3; 11.8; 19.2; 14.3; 17.6 | — |
| SECONDARY Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48 |
11.5; 16.7; 11.8 | — |
| SECONDARY Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48 |
28.0; 33.3; 17.6 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion |
0; 0; 0; 8.3; 33.3; 6.7 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion |
0; 16.7; 9.1; 18.2; 20.0; 27.3 | — |
| SECONDARY Change From Baseline Over Time in HBsAg Levels |
-2.78; -3.35; -2.73; -3.51; -4.17; -3.53 | — |
| SECONDARY Change From Baseline Over Time in HBeAg Levels |
-1.78; -1.77; -1.49; -2.14; -2.39; -2.22 | — |
| SECONDARY Change From Baseline Over Time in HBV DNA Levels |
-6.36; -6.08; -6.26; -6.29; -6.30; -6.07 | — |
| SECONDARY Time to Achieve First HBsAg Seroclearance |
NA; NA; NA | — |
| SECONDARY Time to Achieve First HBeAg Seroclearance |
112; 100.3; NA | — |
| SECONDARY Time to Achieve First HBV DNA <LLOQ |
35.9; 53.3; 38.1 | — |
| SECONDARY Percentage of Participants With HBeAg Levels Below Different Cut-offs |
12.5; 0; 0; 20.8; 14.3; 20.0 | — |
| SECONDARY Percentage of Participants With HBsAg Levels Below Different Cut-offs |
0; 14.3; 0; 4.0; 28.6; 0 | — |
| SECONDARY Percentage of Participants With HBV DNA Levels Below Different Cut-offs |
52.0; 28.6; 40.0; 8.0; 0; 6.7 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough |
3.7; 12.5; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up |
0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) |
1376; 700; 279; 135 | — |
| SECONDARY Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) |
5.53; 3.99; 4.00; 2.99 | — |
| SECONDARY Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) |
315; 381; 36.9; 54.7 | — |
| 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]) |
19109; 12219; 3089; 2117 | — |
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 ( =) 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
Data sourced from ClinicalTrials.gov (NCT04439539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.