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

NCT03650920 | Completed DMC

• 1 other identifier: 5180105
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Failure

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Recipient of HCV positive liver graft

EXPERIMENTAL

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

Interventions

Liver Transplantation PROCEDURE

A HCV negative or previously successfully treated recipient with a HCV positive liver graft

Recipient of HCV positive liver graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Transplant Institute

Loma Linda, California, 92354, United States

Location

Related 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.

  PMID: 28556422 BACKGROUND

Related Links

• Use of Hepatitis C Viremic Donors in Solid Organ Transplantation

MeSH Terms

Conditions

Liver Failure

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Michael L Volk, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Transplant Hepatology

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: September 2, 2018
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)