B-UNITED: Daplusiran/tomligisiran followed by bepirovirsen in people living with chronic Hepatitis B
Research type
Research Study
Full title
A Phase 2b, multi-centre, randomized, partially placebo-controlled, double-blind study to investigate the safety and efficacy of sequential therapy with daplusiran/tomligisiran followed by bepirovirsen in participants with chronic hepatitis B virus on background nucleos(t)ide analogue therapy (B-United).
IRAS ID
1010674
Contact name
Contact email
Sponsor organisation
GSK Research & Development Limited
Research summary
Chronic infection with hepatitis B virus (HBV) is a significant global health problem and progression of the disease can cause long-term liver damage and can even be life-threatening. The most common treatment for chronic HBV infection (CHB) involves taking antiviral medications, known as nucleos(t)ide analogues (NA), for many years.
GSK's conducting a study to investigate a new approach to treat CHB. This involves two experimental medicines given sequentially (one after another); daplusiran/tomligisiran (DAP/TOM), followed by bepirovirsen. These medicines are designed to target and reduce the levels of HBV in the liver. The aim of the study is to see if this experimental treatment can lower the levels of HBV in the body to an undetectable level, which could lead to improved health outcomes for participants with CHB. All participants have the opportunity to receive at least one experimental active treatment.
Globally, approximately 280 participants will take part in the study, with about 10 UK participants.
The study comprises the following stages and participants will be in one of two groups, depending on how much hepatitis B surface antigen (HBsAg - a marker of HBV in the body) they have in their blood;
1) Screening period, up to 60 days, to check if the participant is eligible for the study
2) DAP/TOM or placebo (only participants with low levels of HBsAg can receive a placebo); 6 injections in total given every 4 weeks, over a 24-week period (in addition to NA)
3) Bepirovirsen; 26 doses in total given by injection, once or twice per week, over a 24-week period (in addition to NA)
4) NA only, for 24 weeks
5) Follow up stage, up to 28 weeks
This study is ‘double-blind’, meaning that neither the participant nor the study doctor treating the participant, will know which treatment the participant is receiving.
Study participants will spend approximately 110 weeks in the study. Assessments include physical examination, blood & urine tests, ECG & vital signs.REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0747
Date of REC Opinion
4 Nov 2024
REC opinion
Further Information Favourable Opinion