CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 870 enrolled
Drug / intervention
LDV/SOF +1 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/NCT01701401
NCT01701401Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

Gilead Sciences·interventional·Posted Oct 5, 2012·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating LDV/SOF and RBV for Chronic Hepatitis C Virus. Completed, enrolled 870 participants across 88 sites in 7 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus
CountriesFrance, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2012
Enrollment StartSep 1, 2012
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.7 years ago

Interventions

LDV/SOFdrug

LDV/SOF 90/400 mg FDC tablet administered orally once daily

RBVdrug

RBV 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)