Multi-center Study to Transplant Hepatitis-C Infected Kidneys (MYTHIC)

January 18, 2022 updated by: Raymond Chung

A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus

Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Recipient Inclusion Criteria:

  • Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2
  • Listed for an isolated kidney transplantation
  • Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent
  • No available medically acceptable, compatible living kidney donor
  • Subject must agree to use an effective method of birth control per protocol specifications

Recipient Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant
  • Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study
  • History of HIV
  • HCV RNA positive
  • HBV surface Ag-positive or detectable HBV DNA
  • Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team
  • Presence of clinically significant liver disease
  • Transplant candidate requiring antibody desensitization protocol for transplantation
  • Most recent calculated panel reactive antibody (cPRA) >80%.
  • Prior recipient of a non-renal solid organ transplant

Donor Organ Inclusion Criteria

  • Deceased donor organ with kidney donor profile index (KDPI) ≤0.85
  • HCV RNA-positive

Donor Organ Exclusion Criteria

  • Known prior HCV treatment with direct acting antiviral medication
  • HIV RNA-positive
  • HBV Surface antigen-positive or HBV DNA-positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with glecaprevir/pibrentasvir Fixed Dose Combination
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
Drug: glecaprevir/pibrentasvir treatment
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Other Names:
  • Mavyret treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Undetectable HCV
Time Frame: 12 weeks post treatment
HCV RNA < LLOQ 12 weeks after the last actual dose of G/P
12 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With On-treatment Virologic Failure
Time Frame: During 8 week treatment course
HCV RNA > LLOQ during G/P treatment
During 8 week treatment course
Percentage of Subjects With Post-treatment Virologic Relapse
Time Frame: During 12 week post treatment follow-up
HCV RNA > LLOQ after completion of G/P treatment and prior HCV RNA < LLOQ while on treatment
During 12 week post treatment follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raymond Chung

Collaborators

Johns Hopkins University
University of Pennsylvania
Northwestern University
AbbVie
University of Michigan
Weill Medical College of Cornell University
University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2019

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P003140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Coded data is anticipated to be shared with collaborators in this multi-center consortium

IPD Sharing Time Frame

Real time

IPD Sharing Access Criteria

researchers accessing IPD must be an approved site within the consortium.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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