At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 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 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
In Brief
A Phase 3 clinical trial evaluating LDV/SOF and RBV for Hepatitis C Virus Infection. Completed, enrolled 153 participants across 20 sites in 2 countries.
Detailed Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesEstonia, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionMar 2016
Study CompletionJun 2016
TodayJul 2026
First PostedJun 16, 2015
Enrollment StartJun 17, 2015
Primary CompletionMar 30, 2016
Study CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.0 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)