CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
SOF/VEL +1 moredrug
Likely dose
SOF/VEL 100 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/NCT02300103
NCT02300103Phase 2Completed
CompareCT.gov

An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study

Gilead Sciences·interventional·Posted Nov 24, 2014·Updated Nov 16, 2018

In Brief

A Phase 2 clinical trial evaluating SOF/VEL and RBV for Hepatitis C Virus Infection. Completed, enrolled 69 participants across 30 sites in 4 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesAustralia, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 24, 2014
Enrollment StartDec 1, 2014
Primary CompletionJul 2, 2016
Study CompletionSep 15, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.6 years ago

Interventions

SOF/VELdrug

400/100 mg FDC tablet administered orally once daily

RBVdrug

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