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Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil |
|
| 2 | Active Comparator | Tacrolimus + Steroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of first acute rejection | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall frequences of acute rejection episodes | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
Recipient of an auxiliary graft or in which a bio-artificial liver has been used
Patient is receiving a living related liver transplantation
Patient is requiring steroids as well as chemotherapy prior to transplantation
Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bologna | Italy | |||||
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000077561 | Daclizumab |
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
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| Anti-IL2R AB | Drug | i.v. |
|
|
| Mycophenolate mofetil | Drug | oral |
|
| prednisone | Drug | oral |
|
|
| Genova |
| Italy |
| Milan | Italy |
| Naples | Italy |
| Padova | Italy |
| Roma | Italy |
| Torino | Italy |
| Udine | Italy |
| D000911 |
| Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |