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CertiroBell vs Mycophenolate Mofetil in Primary Living Donor Liver Transplant Recipients
NCT04471441Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2020
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- Chong Kun Dang Holdings
- Modality
- Small Molecules
- Drugs
- everolimus
- Conditions
- liver transplantation
01
Overview
Phase 4, randomised, open-label trial of everolimus in liver transplantation (2 arms), sponsored by Chong Kun Dang Holdings. Primary endpoint: Incidence of composite efficacy failure at 24 weeks. Started Jun 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
CertiroBell Tablet
Everolimus Tab. 1mg BID (total 2mg daily PO), adjusted to maintain blood concentration at 3-8ng/mL
Mycophenolate mofetil Tablet/Capsule
Up to 1.5g BID (total 3g daily), PO
03
Who it enrols
Adult patients who have undergone primary living donor liver transplantation within 4 weeks, without severe systemic infection, recent malignancies, or specific severe laboratory abnormalities.
04
Endpoints
Primary
Incidence of composite efficacy failure
Secondary
Incidence of biopsy-confirmed acute rejection
Pathological results and treatment of acute rejection
Incidence of composite efficacy failure
Overall Survival
Survival rate of transplanted organ
Incidence and recurrence rates of liver cancer
Incidence and recurrence rates of HCV infection
Incidence of CMV infection
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