At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 687 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/NCT02021643

NCT02021643Phase 3Completed

Compare CT.gov

A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection

Gilead Sciences·interventional·Posted Dec 27, 2013·Updated Feb 20, 2018

In Brief

A Phase 3 clinical trial evaluating Sofosbuvir, RBV, and 1 other intervention for Chronic HCV Infection. Completed, enrolled 687 participants across 35 sites in 5 countries.

Detailed Summary

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic HCV Infection

CountriesChina, Hong Kong, South Korea, Taiwan, Vietnam

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartDec 2013

First PostedDec 2013

Primary CompletionAug 2016

Study CompletionNov 2016

TodayJul 2026

First PostedDec 27, 2013

Enrollment StartDec 10, 2013

Primary CompletionAug 12, 2016

Study CompletionNov 3, 2016

TodayJul 2, 2026

Enrollment to primary: 2.7 yearsPosted 12.5 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-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week