NCT04867720

Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients

Multi-center, Single Arm, Open-label, Phase 4 STudy to Evaluate the Efficacy and Safety of CertiroBELL® Tablet Plus TAcrolimus in Primary Living Donor Liver Transplant Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus

Detailed description

This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DRUG	Everolimus	\- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8mg/mL.

Timeline

• Start date: 2021-03-16
• Primary completion: 2022-10-10
• Completion: 2023-02-22
• First posted: 2021-04-30
• Last updated: 2021-04-30

Locations

1 site across 1 country: South Korea