GS-9620 + TDF for participants with Chronic Hepatitis B
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in combination with Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects with Chronic Hepatitis B and who are currently not on Treatment
IRAS ID
192058
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-002017-30
Clinicaltrials.gov Identifier
111,770, IND Number
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Chronic hepatitis B (CHB) is a major global health care challenge and one of the principal causes of chronic liver disease, cirrhosis and hepatocellular carcinoma (HCC) globally. Of the estimated 2 billion people worldwide who have been acutely infected with HBV, up to 350 million have developed CHB and approximately 600,000 people die annually from complications of CHB.
This study will test an experimental medication named GS-9620 in combination with Tenofovir Disoproxil Fumarate (TDF) for the treatment of CHB. The purpose of this study is to determine how well the participant`s body tolerates GS-9620 and how it affects the HBV infection in the participant`s body in combination with provided Tenofovir Disoproxil Fumarate (TDF) treatment.
Participants will be randomised in a 1:2:2:2 ratio to one of the four treatment arms (A: B: C: D) for weekly dosing for a total of 12 doses. This means that, in addition to receiving TDF, participants have 2 out of 7 chances to receive 1 mg GS-9620, 2 out of 7 chances to receive 2 mg GS-9620, 2 out of 7 chances to receive 4 mg GS-9620, and 1 out of 7 chances to receive placebo.
Taking part in this study will last about 54 weeks, including the screening period. During this time, participants will be required to visit the clinic at least 14 times.
Approximately 175 patients will take part in this study in approximately 40 sites globally. The study is open to male and non-pregnant female participants between 18-65 years of age, who meet the study requirements.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0013
Date of REC Opinion
14 Mar 2016
REC opinion
Further Information Favourable Opinion