Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients

Loma Linda University (LLU)

Status: Completed

Conditions: Liver Failure

Treatments: Procedure: Liver Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03650920

5180105

Details and patient eligibility

About

To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV sero-negative liver recipients who are currently listed.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age 18 and older
• Active on the transplant list
• Donor organ with Antibody and nucleic acid test (NAT) positive for HCV
• Graft with F2 fibrosis or less at time of explant
• 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

Exclusion criteria

• Participants co-infected with HIV
• Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known)
• Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV)
• Pregnancy and/or actively breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Recipient of HCV positive liver graft

Experimental group

Description:

A single center, open-label, pilot study examining 10 adult HCV negative liver transplant subjects who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after liver transplantation, unless extenuating clinical circumstances arise (such as fibrosing cholestatic HCV, which would prompt earlier treatment, or non-hepatic comorbidities which would prompt delay in treatment).

Treatment:

Procedure: Liver Transplantation