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| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
| Linical Korea | INDUSTRY |
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This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.
Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.
This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions.
Administration method is following The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADVAGRAF® | Experimental | One arm: Treatment conversion will take placefrom twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVAGRAF® | Drug | Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of acute rejection reaction confirmed by biopsy within 24 weeks after conversion | Incidence rate of acute rejection reaction (%) = The number of subjects with at least one acute rejection reaction / Total number of subjects included in the analysis group * 100 number of subjects in the relevant analysis set * 100 | within 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of acute rejection reaction confirmed by biopsy within 24 weeks after conversion | Severity of acute rejection reactions is defined as the highest severity in a subject who had at least one acute rejection reaction. | within 24 weeks |
| Survival rates of subjects after conversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seoung-Hoon Kim, doctoral | National Cancer Center, Republic of Korea | Principal Investigator |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| at week 24 |
| Survival rate of transplanted organs after conversion | at week 24 |
| Blood concentration of tacrolimus | at week -4, week 0, week 2, week 4, week 8, week 16 and week 24 |