Status:
COMPLETED
Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
Lead Sponsor:
Loma Linda University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.
Eligibility Criteria
Inclusion
- Male or female
- Age 18 and older
- Active on the transplant list
- Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
- HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
- Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
- Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team
Exclusion
- Participants co-infected with HIV
- Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
- Known allergies or hypersensitivity to DAA or ribavarin
- Pregnancy and/or actively breastfeeding
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04452578
Start Date
June 10 2020
End Date
June 17 2022
Last Update
December 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda University Transplant Institute
Loma Linda, California, United States, 92354