At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 95 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 Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
In Brief
A Phase 2 clinical trial evaluating LDV/SOF for Hepatitis C Virus Infection. Completed, enrolled 95 participants across 21 sites in 5 countries.
Detailed Summary
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesBelgium, Germany, Italy, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartJun 2017
Primary CompletionNov 2018
Study CompletionFeb 2019
TodayJul 2026
First PostedJan 30, 2017
Enrollment StartJun 27, 2017
Primary CompletionNov 22, 2018
Study CompletionFeb 14, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.4 years ago
Interventions
LDV/SOFdrug
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily