Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
Completed · Not applicable
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT04452578
- Run by
- Loma Linda University
- People needed
- 2
- Starts
- 2020-06-10
- Expected to finish
- 2022-06-17
- Last updated by the study team
- 2022-12-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Loma Linda University Transplant Institute — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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