Hepatitis C Clinical Trial
— MYTHICOfficial title:
A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus
Verified date | January 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
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 |
United States,
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 |
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