Status:

TERMINATED

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

Lead Sponsor:

Yale University

Conditions:

Liver Transplant; Complications

Hepatitis C

Eligibility:

All Genders

18+ years

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 ...

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 e...

Eligibility Criteria

Inclusion

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

Exclusion

  • Unwilling to consent to post transplant DAA therapy
  • Hepatitis B Virus (HBV) viremia
  • Donor Inclusion Criteria:
  • HCV NAT+
  • Deceased Donor organs
  • HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis
  • Donor

Key Trial Info

Start Date :

July 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 6 2023

Estimated Enrollment :

49 Patients enrolled

Trial Details

Trial ID

NCT04057001

Start Date

July 1 2019

End Date

March 6 2023

Last Update

August 25 2023

Active Locations (1)

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1

Yale School of Medicine

New Haven, Connecticut, United States, 06510