CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 359 enrolled
Drug / intervention
LDV/SOF +5 moredrug
Likely dose
LDV/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/NCT01826981
NCT01826981Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection

Gilead Sciences·interventional·Posted Apr 9, 2013·Updated Nov 16, 2018

In Brief

A Phase 2 clinical trial evaluating LDV/SOF, SOF, and 4 other interventions for Chronic Hepatitis C. Completed, enrolled 359 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesNew Zealand
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2013
Enrollment StartApr 1, 2013
Primary CompletionMar 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.2 years ago

Interventions

LDV/SOFdrug

Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

SOFdrug

SOF 400 mg tablet administered orally once daily

RBVdrug

Ribavirin (RBV) 200 mg 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

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

GS-9669drug

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

VELdrug

Velpatasvir (VEL) tablet(s) administered orally once daily