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

NCT ID: NCT04057001

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-03-06

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

Conditions

Liver Transplant; Complications; Hepatitis C

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients who received a HCV+ liver transplant

Patients on a wait list for a liver transplant who agree to receiving a hepatitis C+ virus positive tested liver transplant.

No interventions assigned to this group

Patients who received a HCV- liver transplant

Patients on a wait list for a liver transplant who agree to receiving a hepatitis C- virus positive tested liver transplant.

No interventions assigned to this group

Eligibility Criteria

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

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

Exclusion Criteria

1. Unwilling to consent to post transplant DAA therapy

2. Hepatitis B Virus (HBV) viremia

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AnnMarie Liapakis, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000022932

Identifier Type: -

Identifier Source: org_study_id