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
- Conditions
- Chronic Hepatitis B Virus InfectionInfections and Infestations
- Registration Number
- ISRCTN15803686
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 37
1. Participants must have chronic hepatitis B virus (HBV) infection
2. 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
1. 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
2. History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices
3. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities
4. Participants with personal/familial history/indicative of immune-mediated disease risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve Hepatitis B Surface Antigen (HBsAg) Seroclearance determined at follow up week 24.
- Secondary Outcome Measures
Name Time Method