Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatitis C
- Liver Transplant, Complications
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 t...
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
Tracking Information
- NCT #
- NCT04057001
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: AnnMarie Liapakis, MD Yale University