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

Liver Transplant Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04069065
• Other study ID #: B93_03LT1901
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: July 31, 2019
• Est. completion date: April 8, 2021

Study information

• Verified date: August 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 146
• Est. completion date: April 8, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of composite efficacy failure	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	until 24 weeks
Secondary	Incidence of biopsy-confirmed acute rejection	episode of biopsy-confirmed acute rejection until 24weeks after conversion	until 24 weeks
Secondary	Pathological results of acute rejection	acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0~9	until 24 weeks
Secondary	Survival rate of transplanted organ		at 24 weeks
Secondary	Survival rate of Patients		at 24 weeks
Secondary	Serum-Cr, eGFR(estimated glomerular filtration rate)	eGFR using MDRD(Modification of Diet in Renal Disease) method	at 24 weeks
Secondary	Evaluate safety of TacroBell SR. cap. from number of participants with adverse events		until 24 weeks