QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

2020P002523

This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

2021-05-01

2023-08-31

2023-08-31

Completed

Early phase I

2

Inclusion Criteria (Recipient) 1. Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR \<15 ml/min/1.73m2 or on renal replacement therapy) 2. Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method 3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team 4. Able to sign informed consent Inclusion Criteria (Deceased Donor) 1. Detectable HCV NAT test 2. KDPI score is less than ≤ 0.850 3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Exclusion Criteria (Recipient) 1. Pregnant or nursing (lactating) women 2. HBV positivity (Ag or DNA) 3. Any contra-indication to kidney transplantation per MGH transplant center protocol 4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician 5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert Exclusion Criteria (Deceased Donor) 1. Confirmed HIV 2. Confirmed HBV positive (surface antigen or HBV DNA positive) 3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

2023-10-10