The Hepatitis C Transplant Collaborative

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    500
  • sponsor
    Baylor Research Institute
Updated on 26 January 2021

Summary

In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.

Description

Organ offers from donors with prior or chronic hepatitis C virus (HCV) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks [1, 2]. The use of HCV antibody-positive (Ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (DAAs) were developed [3-5]. These DAAs target multiple steps in the HCV replication life cycle [6]. Newer, well-tolerated, oral direct-acting antivirals (DAAs) have recently been transforming thoracic transplant outcomes after donor-derived HCV transmission. Moreover, now that HCV nucleic-acid testing (NAT), a polymerase chain reaction (PCR)-based approach to detecting viral activity, is widely available and used on all US donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments.

As a result, the utilization of HCV NAT+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool [7]. Appropriately, clinical safety trials are currently underway, including a multicenter effort led by the PI of this proposal. Moreover, since the last ~2 years many transplant centers across the nation have started transplanting HCV NAT+ donor organs as standard of care. We estimate that the number of HCV+ cardiac transplants is quickly outpacing the number of trial participants. Hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'.

Details
Condition Hepatitis C, Hepatitis C virus, Transplant; Failure, Heart, Transplant; Failure, Heart, Transplant; Failure, Heart, Transplant; Failure, Heart, Transplant; Failure, Heart
Clinical Study IdentifierNCT04493385
SponsorBaylor Research Institute
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hepatitis C virus or Transplant; Failure, Heart or Hepatitis C?
Do you have any of these conditions: Transplant; Failure, Heart or Hepatitis C or Hepatitis C virus?
Recipient of a proven HCV NAT+ donor heart
Re-transplant patients will be included

Exclusion Criteria

Multi-organ transplantation
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