Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00290992
Status:
COMPLETED
Last Update Posted:
2009-03-30
First Post:
2006-02-10
Brief Title:
Rasburicase for Hyperuricemia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Open-Label Multi-Center Study of SR29142 as Uricolytic TherapyProphylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Secondary To investigate the safety in this population and anti-SR29142 antibodies anti-SCP antibodies and pharmacokinetic parameters
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None