Study of liver & blood biomarkers during & after new hep B treatment
Research type
Research Study
Full title
A Phase 2 Randomised, Open-label, Parallel-group, Multicentre Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)ide Analog With or Without JNJ-56136379 in Patients With Chronic Hepatitis B Virus Infection
IRAS ID
281244
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-004475-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 19 days
Research summary
Chronic Hepatitis B infection affects about 292 million people worldwide and despite the current treatments around 680,000 people per year die from liver damage and liver cancer due to Hepatitis B virus (HBV).
The goal of treating chronic HBV 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. Another treatment called Pegylated IFN is associated with a slightly higher rate of clearing HBsAg seroclearance compared to NUCs but it has a lot more side effects than NUCs.
Due to this there is an unmet medical need for HBV treatments. A challenge for developing treatments is that we use blood markers like ‘HBsAg’ to see how well treatments are working, which is helpful, but they do not tell us exactly what is happening in the liver itself. The goal of this study is to use liver biopsies to directly study the viral and immune system events taking place in the liver.
A total of 24 chronic HBV-infected participants will be enrolled. The study comprises:
-4-6-week screening period
-48 weeks of treatment
-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 be assigned to one of two arms to receive study medication:
JNJ-3989+JNJ-6379+NUC
or
JNJ-3898 + NUC
During the study they will have liver biopsies and other tests to check safety.
After 48 weeks of treatment, participants who meet pre-defined criteria stop treatment altogether. They will then be monitored closely during the follow-up period (48 weeks) and can restart NUC if needed.REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/1277
Date of REC Opinion
21 Dec 2020
REC opinion
Further Information Favourable Opinion