At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 601 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/NCT01962441

NCT01962441Phase 3Completed

Compare CT.gov

A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.

Gilead Sciences·interventional·Posted Oct 14, 2013·Updated Jun 20, 2017

In Brief

A Phase 3 clinical trial evaluating SOF, RBV, and 1 other intervention for Hepatitis C. Completed, enrolled 601 participants across 78 sites in 5 countries.

Detailed Summary

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C

CountriesAustralia, Canada, New Zealand, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartSep 2013

First PostedOct 2013

Primary CompletionJan 2015

Study CompletionJul 2016

TodayJul 2026

First PostedOct 14, 2013

Enrollment StartSep 24, 2013

Primary CompletionJan 7, 2015

Study CompletionJul 7, 2016

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 12.7 years ago

Interventions

SOFdrug

400 mg tablet administered orally once daily

RBVdrug

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

180 µg administered via subcutaneous injection once weekly