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Safety and Efficacy of GS-9620 for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Subjects
This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02166047
First received: June 16, 2014
Last updated: August 19, 2014
Last verified: August 2014
Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9620 in virologically suppressed adults with chronic hepatitis B virus (HBV) infection who are currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts. Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of GS-9620 (1, 2, or 4 mg) and all participants will continue on their current oral antiviral treatment for the entire duration of the study. Cohorts A, B, and C will consist of a different treatment period of 4, 8, or 12 weeks, respectively, and will be followed to Week 48. After Cohort A completes treatment, a safety review will be conducted by an external data monitoring committee prior to beginning Cohort B. Another safety review will be conducted after Cohort B completes treatment prior to beginning Cohort C.
Condition Intervention Phase 2
Chronic Hepatitis B
Drug: GS-9620
Drug: Placebo to match GS-9620
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
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发表于 2014-8-23 10:48
