At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 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 Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
In Brief
A Phase 2 clinical trial evaluating LDV/SOF for Hepatitis C Virus Infection. Completed, enrolled 17 participants across 6 sites.
Detailed Summary
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMay 2015
Primary CompletionMar 2016
Study CompletionApr 2016
TodayJul 2026
First PostedJan 29, 2015
Enrollment StartMay 22, 2015
Primary CompletionMar 28, 2016
Study CompletionApr 22, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.4 years ago
Interventions
LDV/SOFdrug
90/400 mg FDC tablet administered orally