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A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04508907
Collaborator
(none)
38
Enrollment
1
Location
1
Arm
26.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors
Actual Study Start Date :
Sep 10, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Pre-emptive Treatment Arm

Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Drug: Mavyret
Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients
Other Names:
  • Zetia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of prevention of HCV viremia in recipients of HCV viremic solid organs [3 months]

      The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.

    2. Graft and patient survival [1 year]

      Study will assess the overall 1 year patient and graft survival.

    Eligibility Criteria

    Criteria

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

    • Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection

    • Willing to accept and consent for accepting hepatitis C positive graft

    Exclusion criteria:

    • Existing chronic liver disease (liver cirrhosis)

    • Concomitant infection with HIV or Chronic hepatitis B

    • Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection

    • Pregnancy (Pregnant patients do not undergo solid organ transplants)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Bashar A Aqel, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bashar Aqel, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04508907
    Other Study ID Numbers:
    • 20-001964
    First Posted:
    Aug 11, 2020
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis

    Study Results

    No Results Posted as of Mar 7, 2022