* Study of siRNA injection, NUC and PegIFNa for people with hepatitis B
Research type
Research Study
Full title
A Phase 2, Open-label, Multicentre Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogues, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection (The PENGUIN-2 Study)
IRAS ID
301545
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-002450-81
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 27 days
Research summary
The purpose of this study is to look at if treating people with hepatitis B infection (HBV) with the study drugs JNJ-73763989 (‘JNJ-3989’ for short, a liver targeted antiviral for chronic hepatitis B), with a nucleoside/nucleotide analogue (also referred to as ‘NUC’), and with pegylated interferon alpha-2a (‘PegIFNa’ for short), is safe and useful.
JNJ-3989, a liver targeted antiviral for chronic hepatitis B, is not approved for use by any Regulatory Authority. NUC and PegIFNa are approved for the treatment of chronic hepatitis B.
JNJ-3989 is given in clinic as an injection. PegIFNa is given as a weekly self-injection at home. The NUC is a tablet which is taken once a day.
This study consists of a Screening Phase of 4-8 weeks, a Treatment Phase of 24 weeks and a Follow-up Phase of 48 weeks. Participants will take JNJ-3989 injection every 4 weeks and a NUC tablet every day. Participants will be randomly assigned to a treatment group for PegIFNa and will take PegIFNa once a week for 12 weeks starting either at Day 1 or starting at Week 12; or for 24 weeks starting at Day 1. The chance of being assigned to each treatment group is 1 in 3 (33.3%)
At study visits a participant will have procedures such as blood and urine tests, physical examinations, ECGs, fibroscans and ultrasounds. Study participation is expected to last between 76-80 weeks.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0307
Date of REC Opinion
16 Nov 2021
REC opinion
Further Information Favourable Opinion