CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
Tenofovir disoproxil fumarate +1 moredrug
Likely dose
Tenofovir disoproxil fumarate 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02174276
NCT02174276Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

Gilead Sciences·interventional·Posted Jun 25, 2014·Updated Jun 4, 2019

In Brief

A Phase 2 clinical trial evaluating Tenofovir disoproxil fumarate and GS-4774 for Chronic Hepatitis B. Completed, enrolled 195 participants across 33 sites in 6 countries.

Detailed Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesCanada, Italy, New Zealand, Romania, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 25, 2014
Enrollment StartJul 24, 2014
Primary CompletionFeb 17, 2016
Study CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.0 years ago

Interventions

Tenofovir disoproxil fumaratedrug

TDF 300 mg tablet administered orally once daily

GS-4774biological

GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses