Study of JNJ-3989+JNJ-6379+NUC in virologically suppressed hep B pts.
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ-73763989+JNJ-56136379+Nucleos(t)ide Analog (NA) Regimen Compared to NA Alone in e Antigen-negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection - the REEF-2 study
IRAS ID
269542
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-002674-31
Duration of Study in the UK
2 years, 2 months, 6 days
Research summary
A goal of treatment for people with chronic hepatitis B is to suppress or stop the virus replicating even after stopping all treatment. Testing negative for ‘hepatitis B surface antigen’ (‘HBsAg’) in the blood 6 months after stopping treatment (having previously tested positive for HBsAg) may be an indicator of this and is called ‘functional cure’.
Many people with hepatitis B take a medicine called a nucleos(t)ide analogue (or ‘NUC’). Current treatment guidelines suggest that the NUC could be stopped in selected people who have been taking their NUC for at least 3 years to see if they achieve functional cure.
This study looks at the effectiveness of stopping the NUC in this type of person, but two thirds of study participants will have 48 weeks taking two study drugs on top of their NUC before stopping all treatment. The remaining third of participants will take dummy drug on top of their NUC. Everyone will be ‘blinded’ so will not know if a participant is receiving study drugs or placebo. The study drugs are JNJ-3989 (an injection given under the skin of the stomach every 4 weeks) and JNJ-6379 (tablets taken once a day).
This study comprises a 4-6-week screening period, 48 weeks of treatment and 48 weeks of follow-up. After consenting for the study, participants undergo assessments to see if they can enter the study. If a participant is eligible, it is decided by chance which treatment they receive. Participants will be asked to come to clinic for further tests and assessments during the treatment and follow-up periods. Twenty-four weeks after stopping treatment, a participant’s HBsAg level will be measured to see if they have achieved functional cure. If there are signs that their hepatitis B is getting worse at any point however, they can re-start their NUC.REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0619
Date of REC Opinion
13 Nov 2019
REC opinion
Further Information Favourable Opinion