Overview

Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant

Status:
Withdrawn
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
All
Summary
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Raymond T. Chung, MD
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Grazoprevir
Ribavirin
Criteria
Inclusion Criteria:

- Recipient is Age ≥ 18 years

- Serum ALT within normal limits with no history of liver disease

- Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high
likelihood of needing aggressive immunosuppression to treat rejection

Exclusion Criteria:

- Sensitization (i.e. PRA >20%)

- Any liver disease in recipient

- Albumin < 3g/dl or platelet count < 75 x 103/mL

- Need for dual organ transplant