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

Not Applicable

Completed

• Conditions: Liver Failure
• Interventions: Procedure: Liver Transplantation

• Registration Number: NCT03650920
• 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 sero-negative liver recipients who are currently listed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Study Start: 2018-09-02
• Primary Completion: 2021-02-19
• Study Completion: 2021-02-19
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recipient of HCV positive liver graft	Liver Transplantation	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).

Primary Outcome Measures

Name	Time	Method
Patient survival rate	From the date of transplant through the last day of 15 month post transplant	Will track all subjects post transplant for 15 months

Trial Locations

Locations (1)

Loma Linda University Transplant Institute; 🇺🇸 Loma Linda, California, United States