Study of different combinations of treatments for people with hep B
Research type
Research Study
Full title
A Phase 2b, Multicentre, Double-blind, Active-controlled, Randomised Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
IRAS ID
263231
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-000622-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 29 days
Research summary
Summary of Research
The purpose of this study is to see how well and how safely two study drugs (called JNJ-3989 and JNJ-6379) work in people who have hepatitis B. Each person taking part in the study will receive JNJ-3989 (an injection given once every 4 weeks) or JNJ-6379 (tablets taken once a day) or dummy injection or dummy tablets (‘placebo’) or a combination of these. These will be given together with a type of medicine already approved for treating hepatitis B called a ‘nucleos(t)ide analogue’ (or ‘NUC’).
The participants, research team and sponsor will be ‘blinded’ during the treatment period so will not know if a participant is receiving active drug or placebo.
This study is made up of a 4 to 6-week screening period, a 48-week treatment period and a 48 to 96-week follow up period.
At screening, participants sign an informed consent form then undergo assessments to see if they can enter the study. These include blood tests, an electrocardiogram and procedures to look at the liver. If a participant is eligible, it will then be decided by chance which treatment they receive. During the treatment and follow-up periods, participants will be asked to come to clinic for further assessments. Participants whose blood test results meet pre-defined criteria at Week 44 of treatment will come off treatment altogether at Week 48 then will be monitored closely during the follow-up period. If there are signs that their hepatitis B is getting worse, they will re-start the NUC. Participants who do not meet the criteria will stop the JNJ-3989/JNJ-6379/placebo after 48 weeks of treatment but will continue taking the NUC. If they then meet the criteria during the follow-up period, they will come off the NUC and be followed up for a further 48 weeks.Summary of Results
Study participants will be provided with a plain language summary in pdf format. This will be done in April 2023 (one year after the last participant last visit date globally).REC name
London - Central Research Ethics Committee
REC reference
19/LO/1240
Date of REC Opinion
20 Aug 2019
REC opinion
Further Information Favourable Opinion