Trials / Completed
CompletedNCT00290992
Rasburicase for Hyperuricemia
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rasburicase (SR29142) |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2006-04-01
- Completion
- 2006-04-01
- First posted
- 2006-02-13
- Last updated
- 2009-03-30
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00290992. Inclusion in this directory is not an endorsement.