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

Withdrawn before enrolling · Phase 4

Conditions studied: Cardiac Transplant Disorder, Hepatitis C

In brief

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.

Key facts

Study ID

NCT03026023

Run by

Raymond T. Chung, MD

People needed

0

Starts

2018-08-01

Expected to finish

2021-06-30

Last updated by the study team

2018-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Masschusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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