Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients

Overview

To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.

Full Title of Study: “Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Experimental: Recipient of HCV positive heart graft
    • A single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation.

Clinical Trial Outcome Measures

Primary Measures

  • Patient Survival Rate
    • Time Frame: 15 months

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female
  • Age 18 and older
  • Active on the transplant list
  • Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
  • 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
  • Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team

Exclusion Criteria

  • Participants co-infected with HIV
  • Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
  • Known allergies or hypersensitivity to DAA or ribavarin
  • Pregnancy and/or actively breastfeeding

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Loma Linda University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dmirty Abramov, Assistant Professor, Loma Linda Medical Center – Loma Linda University
  • Overall Contact(s)
    • Dmitry Abramov, MD, 9095588184, dabramov@llu.edu

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