CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
sofosbuvir/velpatasvirdrug
Likely dose
Not stated in 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.

Search/NCT03819322
NCT03819322Phase 2Completed
CompareCT.gov

Transplantation of Livers of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa®)

Fernanda P Silveira, MD, MS·interventional·Posted Jan 28, 2019·Updated Apr 30, 2026

In Brief

A Phase 2 clinical trial evaluating sofosbuvir/velpatasvir for Liver Transplant and Hepatitis C. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplant, Hepatitis C
CountriesUnited States
CollaboratorsUniversity of Pittsburgh Medical Center

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 28, 2019
Enrollment StartAug 15, 2019
Primary CompletionMar 17, 2025
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.4 years ago

Interventions

sofosbuvir/velpatasvirdrug

12 week, oral, fixed dose