Study of treatment for people co-infected with hepatitis B & D virus
Research type
Research Study
Full title
A Phase 2, Multicentre, Randomised, Double-blind, Placebo‑controlled Study with Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ‑73763989 + Nucleos(t)ide Analogue in Participants Co‑infected with Hepatitis B and Hepatitis D Virus
IRAS ID
284370
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-001249-37
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 4 months, 21 days
Research summary
Only people already infected with hepatitis B virus can get infected with hepatitis D virus (‘HDV’) infection as it is dependent on the hepatitis B virus (‘HBV’) to reproduce. People who have both HBV and HDV may suffer from more serious liver disease than people who only have HBV infection. Currently there is no approved treatment for HDV.
The purpose of this research study is to see if the study drug called ‘JNJ-3989’ is a safe and effective treatment for HDV. JNJ-3989 will be given to study participants along with a nucleos(t)ide analogue or ‘NUC’ which is standardly used in the UK for people with chronic HBV infection.
JNJ-3989 is given by injection every 4 weeks whereas NUCs are tablets taken once a day.
The study comprises a 4-8-week screening period, up to 148 weeks of treatment and 48 weeks of follow-up. After consenting for the study, participants will undergo assessments to see if they can enter the study. If they are eligible, it will be decided by chance if they receive JNJ-3989+NUC for 144 weeks, or a dummy injection+NUC for 52 weeks followed by JNJ-3989+NUC for 96 weeks. There is a 4 in 5 chance that a participant will receive JNJ-3989+NUC all the way through the treatment period, and a 1 in 5 chance that a participant will receive the dummy injection for the first 52 weeks of treatment.
Each participant will be monitored at frequent intervals throughout the treatment and follow-up periods. Participants will be asked to come to clinic for blood and urine tests, ECGs, fibroscans, ultrasounds and to complete questionnaires which ask about their health and how they are feeling. The results from these tests and assessments will help to determine if JNJ-3989 is safe and effective in treating their HDV (and HBV) infection.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/1073
Date of REC Opinion
19 Oct 2020
REC opinion
Further Information Favourable Opinion