CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 328 enrolled
Drug / intervention
Sofosbuvir +2 moredrug
Likely dose
Sofosbuvir 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/NCT01641640
NCT01641640Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

Gilead Sciences·interventional·Posted Jul 17, 2012·Updated May 8, 2014

In Brief

A Phase 3 clinical trial evaluating Sofosbuvir, RBV, and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 328 participants across 56 sites in 2 countries.

Detailed Summary

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.0 years ago

Interventions

Sofosbuvirdrug

Sofosbuvir 400 mg tablet administered orally once daily

RBVdrug

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

PEGdrug

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection