At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 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.
An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease
In Brief
A Phase 2 clinical trial evaluating LDV/SOF for Hepatitis C Virus Infection. Completed, enrolled 10 participants across 1 site.
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) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartMar 2015
Primary CompletionApr 2016
TodayJul 2026
First PostedNov 26, 2014
Enrollment StartMar 2, 2015
Primary CompletionApr 18, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.6 years ago
Interventions
LDV/SOFdrug
90/400 mg fixed dose combination (FDC) tablet administered orally once daily