Phase 2
Completed N=37
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
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT05275023 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 — 0; 0 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 |
0; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest |
11.1; 5.3; 0; 5.3 | — |
| SECONDARY Number of Participants With TEAEs by Severity |
5; 7; 1; 5; 0; 0 | — |
| SECONDARY Number of Participants With Immune Related TEAEs |
0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs) |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Physical Examinations |
0; 2; 2; 1 | — |
| SECONDARY Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology |
11.1; 42.1; 16.7; 0; 16.7; 26.3 | — |
| SECONDARY Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry |
3; 2; 2; 1; 1; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis |
2; 0; 1; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels |
3.25; 3.14; -0.19; -0.17; -0.26; -0.31 | — |
| SECONDARY Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Seroclearance |
0; 0; 0; 5.3 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion |
0; 0; 0; 5.6 | — |
| SECONDARY Time to Achieve HBsAg Seroclearance |
NA | — |
| SECONDARY Time to Achieve HBsAg Seroconversion |
NA | — |
| SECONDARY Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time |
0.83; 0.80; 0.87; 0.72; 0.83; 0.85 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time |
72.2; 78.9; 27.8; 21.1; 66.7; 94.7 | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time |
100.0; 94.7; 100; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have chronic hepatitis B virus (HBV) infection
- Participants must have fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2
Exclusion Criteria
- Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin IgM), hepatitis C virus (HCV) infection (HCV antibody), hepatitis D virus (HDV) infection (HDV antibody), hepatitis E virus (HEV) infection (hepatitis E antibody IgM), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection (laboratory confirmed) 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
- Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities
- Participants with personal/familial history/indicative of immune-mediated disease risk
Data sourced from ClinicalTrials.gov (NCT05275023). 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.