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THINKER: DAA Treatment in HCV-Negative Kidney Transplant Recipients from HCV-Positive Donors
NCT02743897Phase 2
Key facts
- Status
- Completed
- Start
- May 2016
- Primary completion
- Mar 2022
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, open-label, single-arm trial of grazoprevir and glecaprevir in hepatitis C (HCV), sponsored by University of Pennsylvania. Primary endpoints: Number of Subjects Cured at 24 weeks and Number of Subjects With SAE Attributable to HCV Therapy at 52 weeks. Started May 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Direct-acting antiviral treatment for HCV
HCV-negative patients receiving HCV-positive kidney, followed by DAA treatment
03
Who it enrols
HCV-negative patients aged 30-70 with end-stage renal disease (eGFR <15) waitlisted for a kidney transplant, with no available living donor, and willing to receive a kidney from an HCV-positive donor.
04
Endpoints
Primary
Number of Subjects Cured
Number of Subjects With SAE Attributable to HCV Therapy
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