The Hepatitis C Transplant Collaborative

Recruiting

• Conditions: Hepatitis C; Transplant; Failure, Heart

• Registration Number: NCT04493385
• Lead Sponsor: Baylor Research Institute

Brief 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.

Detailed 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'.

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Recipient of a proven HCV NAT+ donor heart.
2. Re-transplant patients will be included.

Exclusion Criteria

1. Multi-organ transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Primary graft dysfunction (PGD)	30 days	Rate of Expected Post-Transplant Risks
Antibody Mediated Rejection rate	6.5 years	Graft rejection rate
Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation	6.5 years	To assess the current status of donor HCV NAT+ cardiac transplantation via retrospective data collection.
Cellular graft rejection rate	6.5 years	Graft rejection rate
Failure versus Cure Rate for HCV NAT+ Heart Transplants	6.5 years	sustained viral response (SVR)-12 (cure-rate) for HCV negative recipient
1 year mortality	1 Year	Number of deaths

Trial Locations

Locations (1)

Baylor Scott & White Health Research Institute; 🇺🇸 Dallas, Texas, United States