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| Name | Class |
|---|---|
| Astellas Pharma Taiwan, Inc. | INDUSTRY |
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To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prograf with Myfortic | Active Comparator |
| |
| Advagraf with Myfortic | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy confirmed acute rejection | during the 6 months post-transplant. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and graft survival rates | during the 6 months post-transplant | |
| Time to first biopsy confirmed acute rejection episode | during the 6 months post-transplant | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung | Taiwan | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 |
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| Advagraf | Drug | oral |
|
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| Myfortic | Drug | oral |
|
|
| Incidence of anti-lymphocyte antibody therapy for treatment of rejection |
| during the 6 months post-transplant. |
| Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs | throughout the study |
| Tainan |
| Taiwan |
| Taipei | Taiwan |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |