A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 20, 2022

Primary Completion Date

May 16, 2023

Study Completion Date

February 28, 2024

Conditions
ESRD
Interventions
DRUG

Glecaprevir/pibrentasvir

Manufacturer is AbbVie, Inc., North Chicago, IL Mavyret® is commercially available and FDA approved for the treatment of HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis and also for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor. An immediate release bilayer oral tablet containing a fixed-dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. The daily dose of glecaprevir/pibrentasvir used will be the standard FDA approved dose: 3 tablets taken once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

Trial Locations (1)

10016

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER