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

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ClinicalTrials.gov Identifier: NCT03781726
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
AbbVie
University of Pennsylvania
Johns Hopkins University
University of Cincinnati
Weill Medical College of Cornell University
University of Michigan
Northwestern University
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Failure Chronic Hepatitis C Drug: glecaprevir/pibrentasvir treatment Phase 4

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus
Estimated Study Start Date : March 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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 Name: Mavyret treatment




Primary Outcome Measures :
  1. Undetectable HCV [ Time Frame: 12 weeks post treatment ]
    HCV RNA < LLOQ 12 weeks after the last actual dose of G/P


Secondary Outcome Measures :
  1. Percentage of subjects with on-treatment virologic failure [ Time Frame: During 8 week treatment course ]
    HCV RNA > LLOQ during G/P treatment

  2. 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



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2
  • Blood group O, A, or B
  • Listed for an isolated kidney transplantation
  • Waiting list priority time

    1. For blood group O or B patients: <912 days of accrued waiting list priority time
    2. For blood group A patients: <730 days of accrued waiting list priority time
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781726


Contacts
Contact: Raymond T Chung, MD 617-724-7562 chung.raymond@mgh.harvard.edu

Locations
United States, Illinois
Northwestern Medicine Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
John Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Christine Durand, MD         
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Robert Fontana, MD         
United States, New York
Weill Cornell Medical Center Not yet recruiting
New York, New York, United States, 10065
Contact: Robert Brown, MD         
United States, Ohio
University of Cincinnati Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: E. Steve Woodle, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Goldberg, MD         
Sponsors and Collaborators
Raymond T. Chung, MD
AbbVie
University of Pennsylvania
Johns Hopkins University
University of Cincinnati
Weill Medical College of Cornell University
University of Michigan
Northwestern University
Investigators
Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital

Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03781726     History of Changes
Other Study ID Numbers: 2018P003140
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded data is anticipated to be shared with collaborators in this multi-center consortium
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Real time
Access Criteria: researchers accessing IPD must be an approved site within the consortium.

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

Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
hemodialysis
renal failure
kidney transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Renal Insufficiency
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic