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COMPLETED
NCT03819322
PHASE2

The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients

Sponsor: Fernanda P Silveira, MD, MS

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2019-08-15

Completion Date

2025-03-17

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

sofosbuvir/velpatasvir

12 week, oral, fixed dose

Locations (1)

UPMC

Pittsburgh, Pennsylvania, United States