B-Well 1
Research type
Research Study
Full title
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B Well 1)
IRAS ID
1006755
Contact name
Belinda Cole
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
Hepatitis B is a serious infection of the liver caused by the Hepatitis B virus Chronic Hepatitis B (CHB) and is defined by the presence of the virus for longer than 6 months after first detection in the blood. Approximately 180,000 people in the UK have the condition. CHB infection increases the risk of liver damage and liver cancer. This study is being conducted by GlaxoSmithline (GSK) in CHB participants who already take nucleoside or nucleotide analogue (NA) medicines which can stop the virus from multiplying but cannot help the body fully clear the virus. The study will investigate whether treatment with 300mg Bepirovirsen can achieve functional cure (eliminate the virus with no further treatment needed) in CHB patients. It will also aim to assess safety, tolerability and efficacy. In the first part of the study, participants will receive two study drug injections or two placebo injections at each visit, along with and their normal NA medicine for 24 weeks. All participants will then discontinue the placebo/study drug and receive NA therapy only for 24 weeks. At week 48, participants will be assessed to see whether they can discontinue NA therapy. Participants who can discontinue NA therapy will remain on the study for a further 48 weeks and participants who remain on NA therapy will remain on the study for a further 24 weeks. Globally, approximately 534 adult participants (>18 years) will take part in the study. In the UK, the study will be run at 3 hospital sites and approximately 7 participants will be included. The study will last for approximately 3 years and participants will need to visit the clinic at least 47 times. After confirming eligibility tests and procedures conducted will include blood/urine tests, physical examinations, vital signs, electrocardiograms (ECG’s), pregnancy tests (if applicable) and questionnaires. Liver imaging or biopsy may be conducted in particpants who show signs of any liver abnormalities.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0455
Date of REC Opinion
8 Aug 2023
REC opinion
Further Information Favourable Opinion