Study of JNJ-3989+JNJ-6379+NUC+pegIFN in pts with hep B and normal ALT
Research type
Research Study
Full title
A Phase 2, randomised, open-label, multicentre study to evaluate efficacy, pharmacokinetics, safety, and tolerability of response-guided treatment with JNJ-73763989 + JNJ-56136379 + nucleos(t)ide analog regimen with or without pegylated interferon alpha-2a in treatment-naïve patients with HBeAg positive chronic hepatitis B virus infection and normal ALT
IRAS ID
283250
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-004978-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 6 days
Research summary
The goal of treating chronic hepatitis B infection is to stop the virus replicating even after stopping treatment. Testing negative for ‘hepatitis B surface antigen’ (‘HBsAg’) in the blood 6 months after stopping all treatment may be an indicator of this and is called ‘functional cure’.
Nucleos(t)ide analogs or ‘NUCs’ which are currently used for treating chronic hepatitis B, rarely achieve functional cure in people with chronic hepatitis B who have a large amount of virus in their blood, test positive for hepatitis B envelope antigen (‘HBeAg-positive’) but their ALT level is normal.
The purpose of this research study is to see if functional cure will be achieved by treating this group of people with two study drugs (‘JNJ-3989’ and ‘JNJ-6379’) plus a NUC with or without pegylated interferon alpha-2a (‘pegIFN alpha-2a’ or 'PegIFN').
JNJ-3989 and peg-IFN-alpha2a are given by injection. JNJ-6379 and NUCs are tablets taken once a day.
The study comprises a 4-6-week screening period, 36-60 weeks of induction treatment, 12 weeks of consolidation treatment and 48 weeks of follow-up.
After consenting for the study, participants undergo assessments to see if they can enter the study. If they are eligible, they will receive JNJ-3989+JNJ-6379+NUC (induction phase). When a participant’s HBsAg level comes down to a certain value or after 60 weeks of treatment (whichever comes first), the participant then receives 12 weeks of consolidation treatment with JNJ-3989+JNJ-6379+NUC with or without peg-IFN-alpha2a. At the end of consolidation treatment, participants who meet pre-defined criteria stop treatment altogether. They will then be monitored closely during the follow-up period (48 weeks) and their HBsAg level measured 24 weeks later to see if they have achieved functional cure.
If there are signs that their hepatitis B is getting worse, they will re-start their NUC. Participants who do not meet the criteria will continue taking their NUC during follow-up.REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0352
Date of REC Opinion
12 Oct 2020
REC opinion
Further Information Favourable Opinion