NCT05275023CompletedPhase 2
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
A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 2 Mar 2022
- Start date
- 30 Jun 2022
- Primary completion date
- 12 Dec 2023
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Hepatitis B
- NCT number
- NCT05275023
- EudraCT number
- 2021-005132-33
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 37
- From 30 Jun 2022 to the primary completion date, 12 Dec 2023
- 26 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| IKEM Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. Pta. de Hierro Majadahonda Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Montecelo Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Hosp. Gral. Univ. Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHRU Nancy Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Glasgow Royal Infirmary Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College London and Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Hacettepe University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ege University Medical Faculty Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Kocaeli University Medical Faculty Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Karadeniz Teknik University Medical Faculty Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
Related publications
- No Impact of Low-Dose Nivolumab Addition to JNJ-73763989 on Hepatitis B Surface Antigen Declines in Chronic Hepatitis B: The OCTOPUS-1 Study.Clin Gastroenterol Hepatol · 2026 · PMID 42320551
This page is information, not medical advice. Discuss any trial with your doctor.