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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650920
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Volk, Loma Linda University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Failure Procedure: Liver Transplantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Investigation Using HCV Positive Liver Grafts in HCV Negative or Previously Successfully Treated Recipients
Actual Study Start Date : September 2, 2018
Actual Primary Completion Date : February 19, 2021
Actual Study Completion Date : February 19, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Recipient of HCV positive liver graft
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).
 Procedure: Liver Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive liver graft


Outcome Measures
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Primary Outcome Measures :
  1. Patient survival rate [ Time Frame: From the date of transplant through the last day of 15 month post transplant ]
    Will track all subjects post transplant for 15 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650920


Locations
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United States, California
Loma Linda University Transplant Institute
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Michael L Volk, MD Loma Linda University
More Information
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Additional Information:

Publications:

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Responsible Party: Michael Volk, Director of Transplant Hepatology, Loma Linda University
ClinicalTrials.gov Identifier: NCT03650920    
Other Study ID Numbers: 5180105
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Volk, Loma Linda University:
HCV
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases