CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 534 enrolled
Drug / intervention
SOF +2 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/NCT01625338
NCT01625338Phase 3Completed
CompareCT.gov

An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Gilead Sciences·interventional·Posted Jun 21, 2012·Updated Nov 9, 2015

In Brief

A Phase 3 clinical trial evaluating SOF, RBV, and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 534 participants across 175 sites in 16 countries.

Detailed Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesAustralia, Austria, Canada, Czechia, Estonia, France, Germany, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2012
Enrollment StartJun 1, 2012
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.0 years ago

Interventions

SOFdrug

SOF 400 mg tablet administered orally once daily

RBVdrug

RBV 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)

Peg-IFNdrug

Peg-IFN 180 μg administered once weekly by subcutaneous injection