Study of JNJ-73763989, Nucleos(t)ide Analogs, and a PD-1 inhibitor in Chronic Hepatitis-B patients
Research type
Research Study
Full title
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.
IRAS ID
1005023
Contact name
David Wright
Contact email
Sponsor organisation
University of Leicester
Eudract number
2021-005132-33
ISRCTN Number
ISRCTN15803686
Research summary
The purpose of this study is to look at if treating people with hepatitis B virus (HBV) infection with the study drugs JNJ‐73763989 (‘JNJ‐3989’ for short, a liver targeted antiviral for chronic hepatitis B), nivolumab (a PD‐1 inhibitor) and nucleos(t)ide analogs (NUC) is safe and will increase your chance of losing hepatitis B surface antigen (HBsAg) (a sign of your hepatitis B infection).
JNJ‐3989 is not approved for use by any Regulatory Authority. Nivolumab is approved for the treatment of some cancers and other indications at higher doses than in this study. It is not approved for the treatment of HBV infection. NUC is approved for the treatment of chronic hepatitis B. JNJ‐3989 is given in clinic as an injection. Nivolumab is given in clinic as an infusion into the vein. NUC is your current hepatitis B treatment tablet.
This study will include adults with chronic hepatitis B between the ages of 18 and 55.
This study consists of a Screening Phase, a Treatment Phase and a Follow‐up Phase. Participants will receive several JNJ‐3989 injections during the treatment period. Nivolumab will be given either once or several times depending on the treatment group. Participants will continue their current NUC daily throughout the study. Treatment groups will be randomly assigned which means that the chance of being assigned to each treatment group is 1 in 2 (50%).
At study visits a participant will have procedures such as blood and urine tests, physical examinations, ECGs, fibroscans and ultrasounds. Study participation is expected to last between 76‐80 weeks.REC name
Wales REC 5
REC reference
22/WA/0077
Date of REC Opinion
3 May 2022
REC opinion
Further Information Favourable Opinion