B-Sure
Research type
Research Study
Full title
A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study
IRAS ID
1004236
Contact name
Belinda Cole
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-000554-26
Clinicaltrials.gov Identifier
Research summary
GSK3228836 (the study drug) is an experimental new drug for treating chronic hepatitis B (CHB) and is not yet approved for use in people living with CHB. CHB is caused by the hepatitis B virus (HBV), which infects the liver and can cause damage. Participants are invited to take part in this study if they have received the study drug in another clinical study, showed a decrease in viral substances. This research study is being done to learn more about CHB and if study drug can improve the treatment of CHB.
-In this study, we will observe if the removal of viral substances in the body and prevention of them from returning, caused by previous treatment with the study drug, can be maintained long term. GSK3228836 or any other study drug is not being supplied or administered in this study.
-This study will include about 450 study participants and will last for approximately 7 years. The total number of participants might increase or decrease due to primary response of Hepatitis B surface antigen in previous treatment studies.
-Participants will not receive GSK3228836 during this study. Participants may receive approved hepatitis B virus treatment (e.g., tenofovir or entecavir) and other non-HBV related medications, as prescribed by your doctor, as part of your routine care. Participants may also receive other clinical measurements suggested by the GP as part of their routine monitoring of CHB.
-If participants are continuing hepatitis B virus treatment (e.g., tenofovir or entecavir), they will be asked to stop the treatment at a planned study visit and be closely monitored after stopping the treatment.
-Participants will be asked what is the health-related quality of life living with CHB after previously receiving GSK3228836 treatment.REC name
Wales REC 3
REC reference
21/WA/0366
Date of REC Opinion
23 Dec 2021
REC opinion
Further Information Favourable Opinion