CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 441 enrolled
Drug / intervention
LDV/SOF +1 moredrug
Likely dose
LDV/SOF 90 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/NCT01768286
NCT01768286Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Jan 15, 2013·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating LDV/SOF and RBV for Chronic Hepatitis C Virus. Completed, enrolled 441 participants across 53 sites.

Detailed Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartJan 1, 2013
Primary CompletionNov 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago

Interventions

LDV/SOFdrug

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

RBVdrug

Ribavirin (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)