QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir… (NCT04515797) | Clinical Trial Compass
TerminatedPhase 4
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
Stopped: Unable to meet enrollment goal prior to drug expiration
United States2 participantsStarted 2021-05-01
Plain-language 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 infection from an HCV-positive donor kidney to an HCV-negative recipient.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Detectable HCV NAT test
✓. KDPI score is less than ≤ 0.850
✓. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation
Exclusion criteria
✕. 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
✕
What they're measuring
1
Number of Participants With Undetectable Blood HCV RNA Level
Timeframe: 12 weeks post last dose of treatment with G/P
✕. 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)