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| Name | Class |
|---|---|
| Pescovitz, Mark D., M.D. | INDIV |
| Roche Pharma AG | INDUSTRY |
| Facet Biotech | INDUSTRY |
The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenapax | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | ||
| Insulin requirements (units/kg/day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D Pescovitz, M.D. | Indiana University - Riley Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University - Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |