Status:
COMPLETED
A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation
Lead Sponsor:
NYU Langone Health
Conditions:
ESRD
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV...
Detailed Description
This is a prospective, open-label, single-center, pilot study. The patient population will include 20 patients who are on the kidney transplant waitlist at NYU Langone Health, are hepatitis C virus (H...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs
- Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation
- Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Stategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage
- Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange
- Able and willing to provide informed consent
- Receive an organ offer for a kidney from a deceased donor that:
- Is HCV NAT positive
- Meets all standard criteria for organ acceptability at NYU Langone Transplant Institute
Exclusion
- HCV RNA positive or history of previously treated HCV
- Evidence of active hepatitis B infection or on active antiviral treatment of HBV
- HIV positivity
- Pregnant or nursing (lactacting) women
- Current use of atazanavir or rifampin
- Known hypersensitivity to glecaprevir and/or pibrentasvir
- Current or history of decompensated liver disease
- Recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant)
- Receive an organ offer for a kidney from a deceased donor that is:
- Confirmed HIV positive
- Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable hepatitis B virus DNA)
- Known to have previously failed DAA therapy for treatment for HCV
- HCV antibody positive, but NAT negative
Key Trial Info
Start Date :
March 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04682509
Start Date
March 20 2022
End Date
February 28 2024
Last Update
June 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016