At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
SOF/VELdrug
Likely dose
SOF/VEL 100 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 Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
In Brief
A Phase 2 clinical trial evaluating SOF/VEL for Chronic Hepatitis C. Completed, enrolled 59 participants across 22 sites in 6 countries.
Detailed Summary
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesAustralia, Canada, Israel, New Zealand, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMar 2017
Primary CompletionAug 2018
Study CompletionNov 2018
TodayJul 2026
First PostedJan 30, 2017
Enrollment StartMar 22, 2017
Primary CompletionAug 13, 2018
Study CompletionNov 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.4 years ago
Interventions
SOF/VELdrug
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily