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

NCT ID: NCT04069065

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-04-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conversion to Once-daily Tacrolimus

Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation

Group Type: EXPERIMENTAL

Conversion to Once-daily Tacrolimus

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

TacroBell slow-release cap.

Eligibility Criteria

Inclusion Criteria

• At least one year after liver transplantation
• Over 20 years old(male or female)
• Patient taking tacrolimus twice daily as a maintenance therapy
• Patients with Tacrolimus blood levels of 3-10 at screening
• Agreement with written informed consent

Exclusion Criteria

• Previously transplanted another organs other than the liver or at the same time
• Diagnosed and clinically treated with acute rejection within the last 6 months
• Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month
• Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled]
• Patients who have positive HIV test result
• Severe systemic infection requiring treatment
• At screening

• White blood cell count < 1,500/mm^3, or platelet < 50,000/mm^3, or Serum-C r> 2.0mg/dl
• Liver function test(T-bilirubin, aspartate aminotransferase, alanine aminotransferase)is over 3 times than upper normal limit
• Patients Taking HCV(hepatitis C virus) Therapeutic Drugs
• Pregnant women or nursing mothers
• Fertile women who not practice contraception with appropriate methods
• Participated in other trial within 4 weeks
• In investigator's judgment

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

B93_03LT1901

Identifier Type: -

Identifier Source: org_study_id