Fine Needle Aspiration Study in Participants with Chronic Hepatitis B
Research type
Research Study
Full title
B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping
IRAS ID
279794
Contact name
Patrick Kennedy
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2020-002000-39
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 8 months, 4 days
Research summary
Chronic (long term) Hepatitis B is an infection of the liver caused by a virus that is spread through blood and body fluids and is often treated with medications to keep the virus under control.
This study, sponsored by GlaxoSmithKline, is being done to see if the study drug can improve the treatment of Hepatitis B. An important part of this study is that it will look at the way the study drug changes cells of the immune system in the liver and whether this can help control the Hepatitis B infection. This is important because it could help reduce the chances of the infection returning once treatment is stopped.
The study drug works by stopping the production of viral proteins in infected cells of the liver. These viral proteins interfere with the immune system’s ability to control the infection in infected patients, and therefore thought that by reducing the viral proteins the study drug may help control the Hepatitis B infection.
About 24 people will take part. All participants will receive the same study treatment as an injection given under the skin. During the study participants will continue to receive their normal standard of care treatment.
There will be a 45-day screening window followed by a 12-week treatment period, and a 24-week clinic follow up period. Participants will need to attend the hospital clinic twice a week for the first 2 weeks, once a week through Week 14, once at Week 16, and once every 4 weeks thereafter.
During the study, participants will have various safety assessments, blood tests and a procedure (called fine needle aspiration where a needle will be passed into the liver to remove cells for analysis), which will be repeated several times.
Participates will be in the study for a total of 45 weeks.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0304
Date of REC Opinion
26 Oct 2020
REC opinion
Further Information Favourable Opinion