Cardiac Transplant Disorder, Hepatitis C
Conditions
Keywords
Heart Transplant, Cardiac Transplant, Hepatitis C, Zepatier
Brief 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.
Detailed description
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.
Interventions
DRUGCombindation 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.
Sponsors
Merck Sharp & Dohme LLC
Raymond T. Chung, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Undetectable HCV | 12 Weeks post treatment | Negative HCV viral RNA at 12 weeks after the last dose of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation | Upto 16 Weeks | Safety and tolerability of grazoprevir and elbasvir in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient. |
Countries
United States
Outcome results
None listed