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

Liver Failure Clinical Trial

Official title:

Pilot Investigation Using HCV Positive Liver Grafts in HCV Negative or Previously Successfully Treated Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650920
• Other study ID #: 5180105
• Status: Completed
• Phase: N/A
• Start date: September 2, 2018
• Est. completion date: February 19, 2021

Study information

• Verified date: March 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure

Intervention

Procedure:
• Liver Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive liver graft

Locations

Country	Name	City	State
United States	Loma Linda University Transplant Institute	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival rate	Will track all subjects post transplant for 15 months	From the date of transplant through the last day of 15 month post transplant

External Links

•   Use of Hepatitis C Viremic Donors in Solid Organ Transplantation