Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
Not Applicable
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT04452578
- Lead Sponsor
- Loma Linda University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Patient Survival Rate 15 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Loma Linda University Transplant Institute
🇺🇸Loma Linda, California, United States