Status:
UNKNOWN
Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Liver Transplant
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 Tacroli...
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 ha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04069065
Start Date
July 31 2019
End Date
April 8 2021
Last Update
August 28 2019
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea