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

Chong Kun Dang

Status and phase

Unknown

Phase 4

Conditions

Liver Transplant

Treatments

Drug: Conversion to Once-daily Tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT04069065

B93_03LT1901

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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