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.
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Northwestern Medicine
Chicago, Illinois, United States
John Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Number of Participants With Undetectable HCV
HCV RNA \< LLOQ 12 weeks after the last actual dose of G/P
Time frame: 12 weeks post treatment
Percentage of Subjects With On-treatment Virologic Failure
HCV RNA \> LLOQ during G/P treatment
Time frame: During 8 week treatment course
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
Time frame: During 12 week post treatment follow-up
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Weill Cornell Medical Center
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States