At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 114 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, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
In Brief
A Phase 2 clinical trial evaluating LDV/SOF for Hepatitis C Virus Infection. Completed, enrolled 114 participants across 5 sites in 4 countries.
Detailed Summary
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesAustria, France, Germany, Italy
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionMar 2016
Study CompletionJun 2016
TodayJul 2026
First PostedSep 29, 2014
Enrollment StartOct 14, 2014
Primary CompletionMar 24, 2016
Study CompletionJun 16, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.8 years ago
Interventions
LDV/SOFdrug
90/400 mg FDC tablet administered orally once daily