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The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
Sponsor: Amit D Tevar, MD
Summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney 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 Kidneys 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
30
Start Date
2019-05-29
Completion Date
2026-04-01
Last Updated
2025-11-06
Healthy Volunteers
No
Conditions
Interventions
sofosbuvir/velpatasvir
12-week, oral, fixed-dose
Locations (1)
UPMC
Pittsburgh, Pennsylvania, United States