Research Study

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
Principal Investigator 
Eric M. Yoshida

Overview

Body Locations and Systems 
Hepatitis B
ClinicalTrials.gov# 
NCT02166047
Status 
Closed to Recruitment
Study Start/End 
Oct 9, 2014 to Jul 1, 2017
Locations 
Diamond Health Care Centre, Vancouver General Hospital
Name/Title 
Jo-Ann Ford, Study Coordinator
Phone 
604-875-5705
Email Address 
Joann.ford@vch.ca
Purpose of Study 

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.

Eligibility 

Visit ClinicalTrials.gov for more information.

 

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.