CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 421 enrolled
Drug / intervention
SOF +3 moredrug
Likely dose
SOF 400 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/NCT01682720
NCT01682720Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

Gilead Sciences·interventional·Posted Sep 11, 2012·Updated Oct 9, 2014

In Brief

A Phase 3 clinical trial evaluating SOF, RBV, and 2 other interventions for Hepatitis C. Completed, enrolled 421 participants across 77 sites in 10 countries.

Detailed Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustria, Estonia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2012
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.8 years ago

Interventions

SOFdrug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBVdrug

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Placebo to match SOFdrug

Placebo to match SOF administered orally once daily

Placebo to match RBVdrug

Placebo to match RBV administered orally in a divided daily dose