Back to resultsHepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients
Primary Purpose
Liver Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liver Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure focused on measuring HCV
Eligibility 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
Sites / Locations
- Loma Linda University Transplant Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recipient of HCV positive liver graft
Arm 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).
Outcomes
Primary Outcome Measures
Patient survival rate
Will track all subjects post transplant for 15 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03650920
Brief Title
Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients
Official Title
Pilot Investigation Using HCV Positive Liver Grafts in HCV Negative or Previously Successfully Treated Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
HCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recipient of HCV positive liver graft
Arm Type
Experimental
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Liver Transplantation
Intervention Description
A HCV negative or previously successfully treated recipient with a HCV positive liver graft
Primary Outcome Measure Information:
Title
Patient survival rate
Description
Will track all subjects post transplant for 15 months
Time Frame
From the date of transplant through the last day of 15 month post transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Volk, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Transplant Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28556422
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28556422
Description
Use of Hepatitis C Viremic Donors in Solid Organ Transplantation
Learn more about this trial
Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients
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