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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion to Once-daily Tacrolimus | Experimental | Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conversion to Once-daily Tacrolimus | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite efficacy failure | composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure | until 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-confirmed acute rejection | episode of biopsy-confirmed acute rejection until 24weeks after conversion | until 24 weeks |
| Pathological results of acute rejection | acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0~9 |
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Inclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| until 24 weeks |
| Survival rate of transplanted organ | at 24 weeks |
| Survival rate of Patients | at 24 weeks |
| Serum-Cr, eGFR(estimated glomerular filtration rate) | eGFR using MDRD(Modification of Diet in Renal Disease) method | at 24 weeks |
| Evaluate safety of TacroBell SR. cap. from number of participants with adverse events | until 24 weeks |