Rasburicase for Hyperuricemia
|ClinicalTrials.gov Identifier: NCT00290992|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : March 30, 2009
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 or disease||Intervention/treatment||Phase|
|Nutritional and Metabolic Diseases||Drug: rasburicase (SR29142)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2005|
|Primary Completion Date :||April 2006|
|Study Completion Date :||April 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290992
|Study Director:||Keiji OHNO||Sanofi|