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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04057001
Collaborator
(none)
75
Enrollment
1
Location
84
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)
    Actual Study Start Date :
    Jul 1, 2019
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Jun 30, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Recipient 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale School of Medicine New Haven Connecticut United States 06510

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: AnnMarie Liapakis, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT04057001
    Other Study ID Numbers:
    • 2000022932
    First Posted:
    Aug 14, 2019
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis

    Study Results

    No Results Posted as of Mar 22, 2022