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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03650920
Other study ID # 5180105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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