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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00290992 |
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) |
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:
Responsible Party: | sanofi-aventis ( Study director ) |
Study ID Numbers: | ACT5080, SR29142 |
Study First Received: | February 10, 2006 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00290992 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
urate oxidase, hyperuricemia, lymphoma, leukemia |
Leukemia Uric Acid Metabolic Diseases Hyperuricemia |
Tumor Lysis Syndrome Metabolic disorder Rasburicase Lymphoma |
Pathologic Processes Therapeutic Uses Antirheumatic Agents Gout Suppressants Pharmacologic Actions |