At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 384 enrolled
Drug / intervention
LDV/SOFdrug
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 Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
In Brief
A Phase 3 clinical trial evaluating LDV/SOF for Chronic HCV Infection. Completed, enrolled 384 participants across 45 sites in 3 countries.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic HCV Infection
CountriesChina, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionJul 2017
Study CompletionSep 2017
TodayJul 2026
First PostedDec 27, 2013
Enrollment StartDec 10, 2013
Primary CompletionJul 8, 2017
Study CompletionSep 29, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.5 years ago
Interventions
LDV/SOFdrug
90/400 mg FDC tablet administered orally once daily without regard to food