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

Sponsor

Loma Linda University (Other)

Overall Status

Completed

CT.gov ID

NCT03650920

Collaborator

(none)

Enrollment

Location

Arm

29.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Sep 2, 2018

Actual Primary Completion Date :

Feb 19, 2021

Actual Study Completion Date :

Feb 19, 2021

Arms and Interventions

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

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Transplant Institute	Loma Linda	California	United States	92354

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: Michael L Volk, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Use of Hepatitis C Viremic Donors in Solid Organ Transplantation

Publications

Levitsky J, Formica RN, Bloom RD, Charlton M, Curry M, Friedewald J, Friedman J, Goldberg D, Hall S, Ison M, Kaiser T, Klassen D, Klintmalm G, Kobashigawa J, Liapakis A, O'Conner K, Reese P, Stewart D, Terrault N, Theodoropoulos N, Trotter J, Verna E, Volk M. The American Society of Transplantation Consensus Conference on the Use of Hepatitis C Viremic Donors in Solid Organ Transplantation. Am J Transplant. 2017 Nov;17(11):2790-2802. doi: 10.1111/ajt.14381. Epub 2017 Jul 1.

Responsible Party:

Michael Volk, Director of Transplant Hepatology, Loma Linda University

ClinicalTrials.gov Identifier:

NCT03650920

Other Study ID Numbers:

5180105

First Posted:

Aug 29, 2018

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Volk, Director of Transplant Hepatology, Loma Linda University

HCV

Additional relevant MeSH terms:

Liver Failure

Study Results

No Results Posted as of Mar 18, 2022