NCT04069065

Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)

Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Conversion to TacroBell SR Cap.(Once-Daily Tacrolimus) in Patients Undergoing Maintenance Therapy With Twice-Daily Tacrolimus After Liver Transplantation.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (estimated)
• 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 conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.

Detailed description

This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus. Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DRUG	Conversion to Once-daily Tacrolimus	* Orally, once-daily in the morning * The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~10ng/ml.

Timeline

• Start date: 2019-07-31
• Primary completion: 2021-02-22
• Completion: 2021-04-08
• First posted: 2019-08-28
• Last updated: 2019-08-28

Locations

1 site across 1 country: South Korea