Recruiting

Hepatitis C

Sponsor:

Baylor Research Institute

Code:

NCT04493385

Conditions

Transplant; Failure, Heart

Hepatitis C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Transplant; Failure, Heart

Hepatitis C

Study ID

NCT04493385

Start date

Sep 16, 2019

Status verified date

Jan, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation [ Time Frame: 6.5 years ]
  • Failure versus Cure Rate for HCV NAT+ Heart Transplants [ Time Frame: 6.5 years ]
  • Rate of Primary graft dysfunction (PGD) [ Time Frame: 30 days ]
  • 1 year mortality [ Time Frame: 1 Year ]
  • Cellular graft rejection rate [ Time Frame: 6.5 years ]
  • Antibody Mediated Rejection rate [ Time Frame: 6.5 years ]

Central Contacts and Locations

Central contacts

Joost Felius, PhD

214-818-8943Joost.Felius@BSWHEALTH.ORG

Locations

Baylor Scott & White Health Research Institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Joost Felius, PhD

214-818-8943Joost.Felius@BSWHEALTH.ORG

More Information

Sponsor

Baylor Research Institute

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-01-22.