CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 527 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/NCT01497366
NCT01497366Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection

Gilead Sciences·interventional·Posted Dec 22, 2011·Updated Apr 2, 2014

In Brief

A Phase 3 clinical trial evaluating Sofosbuvir, PEG, and 1 other intervention for Hepatitis C. Completed, enrolled 527 participants across 97 sites in 8 countries.

Detailed Summary

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, Canada, Italy, Netherlands, New Zealand, Puerto Rico, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 22, 2011
Enrollment StartDec 1, 2011
Primary CompletionJan 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.5 years ago

Interventions

Sofosbuvirdrug

Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

PEGdrug

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

RBVdrug

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose * Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg * Dose of PEG+RBV group: 800 mg