drugset / Trial / NCT03222531
Expanding the Pool in Orthotopic Heart Transplantation
Non-randomizedParallel-groupOpen-labelOther
Summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart 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
- 2017-08-01
- Primary completion
- 2026-06-02
- Completion
- 2026-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 100 mg | Oral |