Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
| Status: | Withdrawn |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | August 1, 2018 |
| End Date: | June 30, 2021 |
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.
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.
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.
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
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