Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-31 @ 6:33 PM
Study NCT ID:
NCT00290992
Status:
COMPLETED
Last Update Posted:
2009-03-30
First Post:
2006-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rasburicase for Hyperuricemia
Sponsor:
Sanofi
Organization:
Study Overview
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
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: