Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT04349306
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2020-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
An Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin¿s Lymphoma and Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2022-04
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:
RAISE
Brief Summary:
Primary Objective:
To evaluate safety of rasburicase in pediatric patients with NHL and AL
Secondary Objective:
To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
To evaluate safety of rasburicase in pediatric patients with NHL and AL
Secondary Objective:
To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
Detailed Description:
Study duration per participants is approximatively 14 days including a 5-day treatment period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1233-0737 | OTHER | UTN | View |