At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 111 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.
A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection
In Brief
A Phase 2 clinical trial evaluating LDV/SOF and RBV for Hepatitis C Virus Infection. Completed, enrolled 111 participants across 15 sites.
Detailed Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedApr 2015
Primary CompletionDec 2015
Study CompletionJan 2016
TodayJul 2026
First PostedApr 10, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.2 years ago
Interventions
LDV/SOFdrug
90/400 mg FDC tablet administered orally once daily
RBVdrug
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)