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A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
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 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients. Patients will be selected based on their diminished likelihood of receiving a heart from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Masschusetts General Hospital
Boston, Massachusetts, United States
Start Date
August 1, 2018
Primary Completion Date
December 31, 2020
Completion Date
June 30, 2021
Last Updated
December 20, 2018
Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
DRUG
Lead Sponsor
Raymond T. Chung, MD
Collaborators
Data Source & Attribution
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