NCT04471441

Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.

Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of CertiroBell® Compared With Mycophenolate Mofetil in Primary Living Donor Liver Transplant Recipients.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

Detailed description

This study is multi-center, open-label, randomized controlled phase 4 study to evaluate the efficacy and safety of certirobell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients. On the first visit the patients scheduled to be operated liver transplant in 35 days will be conducted screening. Patients who meet the criteria of this clinical trial will be randomized to CertiroBell or mycophenolate mofetil on the second visit. Each group will take CertiroBell or mycophenolate mofetil and will conduct scheduled tests with 5 additional visits.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DRUG	Everolimus Tab.	After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/mL.
DRUG	Mycophenolate mofetil Tab./Cap.	Up to 1.5g BID(total 3g daily), PO

Timeline

• Start date: 2020-06-30
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2020-07-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: South Korea