Status:
COMPLETED
HCV Positive Heart Donors
Lead Sponsor:
NYU Langone Health
Conditions:
Heart Failure
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests posit...
Eligibility Criteria
Inclusion
- Listed for an isolated heart transplant at NYU Langone Health
- Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
- No active illicit substance abuse
- Weight at least 50kg
- Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
- Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
- Able and willing to provide informed consent
Exclusion
- HIV positive
- HCV RNA positive or history of previously treated HCV
- Hepatitis B surface antigen positive or on active antiviral treatment for HBV
- Pregnant or nursing (lactating) women
- Use of strong CYP3A inducers
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03382847
Start Date
January 5 2018
End Date
May 6 2020
Last Update
February 3 2021
Active Locations (1)
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1
NYU Langone Transplant Institute
New York, New York, United States, 10016