Clinical trial

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

Name

20-01386

Description

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) in kidney transplant recipients who receive a kidney from a donor with HCV.

Trial arms

Trial start

2022-03-20

Estimated PCD

2023-05-16

Trial end

2024-03-14

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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).

Arms:

Study group

Other names:

Mavyret

Size

Primary endpoint

Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia

Visit 2 (Day 1) , Visit 3 (Day 3) , Visit 4 (Day 7), Visit 5 (Day 13), Visit 16 (Day 365)

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2024-03-01

1 organization

1 product

1 indication

Organization

NYU Langone Health

Product

Glecaprevir/pibrentasvir

Indication

End-Stage Renal Disease