Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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.
Detailed Description
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) in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05275023
Start Date
June 30 2022
End Date
May 31 2024
Last Update
April 25 2025
Active Locations (26)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
2
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
3
IKEM
Prague, Czechia, 140 21
4
Hopital Beaujon
Clichy, France, 92110