Status:
TERMINATED
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Kidney Failure
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 infecti...
Detailed Description
The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Recipient)
- 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)
- 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
- No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
- Able to sign informed consent
- Inclusion Criteria (Deceased Donor)
- Detectable HCV NAT test
- KDPI score is less than ≤ 0.850
- Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation
- Exclusion Criteria (Recipient)
- Pregnant or nursing (lactating) women
- HBV positivity (Ag or DNA)
- Any contra-indication to kidney transplantation per MGH transplant center protocol
- Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
- Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert
- Exclusion Criteria (Deceased Donor)
- Confirmed HIV
- Confirmed HBV positive (surface antigen or HBV DNA positive)
- Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04515797
Start Date
May 1 2021
End Date
August 31 2023
Last Update
December 3 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114