At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 647 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.
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
In Brief
A Phase 3 clinical trial evaluating LDV/SOF and RBV for Chronic Hepatitis C Virus. Completed, enrolled 647 participants across 52 sites.
Detailed Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionDec 2013
Study CompletionMar 2014
TodayJul 2026
First PostedMay 10, 2013
Enrollment StartMay 1, 2013
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.1 years ago
Interventions
LDV/SOFdrug
LDV 90 mg/SOF 400 mg 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)