drugset / Trial / NCT03809533
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
Phase 2
Active not recruiting
30 enrolled
Amit D Tevar, MD
University of Pittsburgh Medical Center · collab
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2019-05-29
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sofosbuvir | Small molecule | 400 mg | — |
| Subject | velpatasvir | Other / unclassified | 100 mg | — |