Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL) (NCT04069065) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
South Korea146 participantsStarted 2019-07-31
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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