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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 (NCT03026023)

Merck Sharp & Dohme Corp.
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.
  • Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
    HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.
    • Zepatier
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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
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.

1 locations

United States (1)
  • Masschusetts General Hospital
    Not specified
    Boston, Massachusetts, United States, 02114
Status:
suspended
Type:
Interventional
Phase:
Start:
30 November, 2017
Updated:
03 October, 2017
Participants:
11
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