At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 85 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 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
In Brief
A Phase 2 clinical trial evaluating LDV/SOF for Chronic Genotype 4 HCV and Chronic Genotype 5 HCV. Completed, enrolled 85 participants across 5 sites.
Detailed Summary
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Genotype 4 HCV, Chronic Genotype 5 HCV
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedMar 2014
Primary CompletionNov 2014
Study CompletionFeb 2015
TodayJul 2026
First PostedMar 7, 2014
Enrollment StartMar 1, 2014
Primary CompletionNov 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.3 years ago
Interventions
LDV/SOFdrug
LDV/SOF (90/400 mg) FDC tablet administered orally once daily