NCT04057001

Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study

Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.

Detailed description

The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can. Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study. Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes. Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure. Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes

Conditions

• Liver Transplant; Complications
• Hepatitis C

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2019-08-14
• Last updated: 2023-08-25

Locations

1 site across 1 country: United States