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

Terminated

• Conditions: Hepatitis C; Liver Transplant; Complications

• Registration Number: NCT04057001
• Lead Sponsor: Yale University

Brief 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

Study Timeline

• Study First Submitted: 2019-06-13
• Study Start: 2019-07-01
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Adult patients > or = 18 years of age
2. Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK)
3. Current HCV NAT- status
4. Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers

Recipient

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Exclusion Criteria

1. Unwilling to consent to post transplant DAA therapy
2. Hepatitis B Virus (HBV) viremia

Donor Inclusion Criteria:

1. HCV NAT+
2. Deceased Donor organs
3. HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis

Donor Exclusion Criteria:

1. Bilirubin >3
2. Positive nucleotide testing for HBV
3. Radiographic, laboratory or other clinical evidence of portal hypertension
4. Fibrosis on pre-procurement liver biopsy fibrosis > F1 or fibroscan >7 (if both are done and discordant, use biopsy to determine eligibility

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Transplant	5 years	Number of days between date of adding patient to the waitlist and transplant date comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).

Secondary Outcome Measures

Name	Time	Method
Wait list Mortality	5 years	Number of days between adding patient to the waitlist to death on the waitlist comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States