Multi-center Study to Transplant Hepatitis-C Infected Kidneys

Hepatitis C Clinical Trial

— MYTHIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781726
• Other study ID #: 2018P003140
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency

Intervention

Drug:
• glecaprevir/pibrentasvir treatment
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	John Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern Medicine	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Weill Cornell Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (8)

Lead Sponsor	Collaborator
Raymond Chung	AbbVie, Johns Hopkins University, Northwestern University, University of Cincinnati, University of Michigan, University of Pennsylvania, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Undetectable HCV	HCV RNA < LLOQ 12 weeks after the last actual dose of G/P	12 weeks post treatment
Secondary	Percentage of Subjects With On-treatment Virologic Failure	HCV RNA > LLOQ during G/P treatment	During 8 week treatment course
Secondary	Percentage of Subjects With Post-treatment Virologic Relapse	HCV RNA > LLOQ after completion of G/P treatment and prior HCV RNA < LLOQ while on treatment	During 12 week post treatment follow-up