At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 255 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 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
In Brief
A Phase 3 clinical trial evaluating LDV/SOF and RBV for Hepatitis C Virus Infection. Completed, enrolled 255 participants across 4 sites.
Detailed Summary
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesEgypt
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartSep 2015
Primary CompletionNov 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedJul 1, 2015
Enrollment StartSep 7, 2015
Primary CompletionNov 11, 2016
Study CompletionFeb 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 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 based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)