* TH HBV ASO-001
Research type
Research Study
Full title
A phase 2, single-blinded, randomised, controlled multi-country study to evaluate the safety, reactogenicity, efficacy and immune response following sequential treatment with an anti-sense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy.
IRAS ID
1004149
Contact name
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals
Eudract number
2021-003567-10
Clinicaltrials.gov Identifier
Research summary
Hepatitis B is a serious infection of the liver caused by the Hepatitis B virus Chronic Hepatitis B (CHB) 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 medicines which can stop the virus from multiplying but cannot help the body fully clear the virus. The study will investigate the sequential treatment of two GSK compounds GSK3228836 (study drug ‘ASO’) and GSK3528869A (study vaccine). The aim is to find out if the treatment with the study drug followed by the vaccine is safe, well-tolerated, works well and helps treat CHB.
In the first part of the study all participants will receive the study drug. It will be given as two injections at each visit. Half of the participants will be treated for 24 weeks and the other half for 12 weeks. In the second part of the study participants will receive the vaccine or placebo. These will be given as one injection every 8 weeks, for a total of 4 times over 24 weeks. The participant will be regularly monitored for up to 2 years after the last injection.
Globally, approximately 184 participants who are between 18 and 65 years of age will take part in this study. In the UK the study will be run at hospital sites and approximately 7 participants will be included. The study will last for approximately 3 years and the participants would need to visit the clinic at least 40 times.
After confirming eligibility tests and procedures conducted will include blood/urine tests, physical examinations, vital signs, pregnancy tests, electrocardiograms (ECGs), liver ultrasound, Fibroscan and questionnaire completion.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0319
Date of REC Opinion
20 Dec 2021
REC opinion
Further Information Favourable Opinion