Rasburicase for Hyperuricemia
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.
- Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
- G6PD activity will be measured in only patients who demonstrate hemolysis.
- Anti-SR29142 antibody and Anti-SCP antibody will be measured.
- PK parameters.
|Study Start Date:||June 2005|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290992
|Study Director:||Keiji OHNO||Sanofi|