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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00290992 |
Purpose
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration. Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.
| Condition | Intervention | Phase |
|---|---|---|
|
Nutritional and Metabolic Diseases |
Drug: rasburicase (SR29142) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome |
| Enrollment: | 30 |
| Study Start Date: | June 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:
Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Study director ) |
| Study ID Numbers: | ACT5080 |
| Study First Received: | February 10, 2006 |
| Last Updated: | March 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00290992 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
urate oxidase, hyperuricemia, lymphoma, leukemia |
|
Leukemia Uric Acid Metabolic Diseases Hyperuricemia Tumor Lysis Syndrome |
Antirheumatic Agents Rasburicase Metabolic Disorder Lymphoma |
|
Pathologic Processes Metabolic Diseases Therapeutic Uses Hyperuricemia |
Antirheumatic Agents Gout Suppressants Rasburicase Pharmacologic Actions |