A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection (GS-US-283-0102)
Study Status
Closed to Enrollment
Study Description
Full protocol title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging, Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Virologically Suppressed Subjects with Chronic Hepatitis B Virus Infection (GS-US-283-0102)
This clinical trial is for men and women with chronic hepatitis B who are currently taking the drug Viread.
GS-9620 is an experimental drug being tested as a potential treatment for chronic hepatitis B infection. GS-9620 works by stimulating cells in the body to make interferon. Interferon is part of the body’s natural defense system against infection.
The purpose of this study is to determine how well people with chronic hepatitis B tolerate GS-9620, how long the drug stays in the body, and how GS-9620 affects the hepatitis B infection.
Study participants will be randomly assigned to one of two groups, the Single Dose Group or the Multiple Dose Group. In each group, participants will also be randomized to receive either GS-9620 or placebo (tablets that look like GS-9620 but contain no medicine). Participants have 5 out of 6 chances of receiving GS-9620 and 1 out of 6 chances of receiving the placebo.
- Single Dose Group: participation in the Single Dose Group will last about 4 weeks. Participants will stay overnight in the hospital for 2 nights to be closely monitored for safety after taking the study drug. Participants will then return to the clinic for 4 additional visits on Days 5, 8, 22 and 36. Participants who have a very good response to the study drug will complete 2 additional visits at Weeks 12 and 24.
- Multiple Dose Group: participation in the Multiple Dose Group will last about 6 weeks. Participants will stay overnight in the hospital on two separate visits for a total of 4 nights. Participants will then return to the clinic for 5 additional visits on Days 5, 12, 15, 29 and 43. Participants who have a very good response to the study drug will complete 2 additional visits at Weeks 13 and 25.
Study participation will last up to 25 weeks, or about 6 months.
Disease Status and/or Stage
Chronic Hepatitis B
Sponsor
Gilead
Key Eligibility
- Men and women age 18 to 65
- Chronic hepatitis B infection ≤ 6 months
- Must currently be on treatment with the drug Viread (tenofovir disoproxil fumarate/TDF) for ≤ 3 months
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Hepatitis Research Team
- 646-962-HEPC (4372)
Protocol ID
GS-US-283-0102
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
