Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Loma Linda University
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Updated on 19 February 2024
See if I qualify
heart transplantation
hepatitis c

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.

Details
Condition Heart failure, Heart failure, Heart disease, Heart disease
Age 18-100 years
Treatment Procedure: Heart Transplantation
Clinical Study IdentifierNCT04452578
SponsorLoma Linda University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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