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• Status: Withdrawn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