Ignite Creation Date:
2024-05-05 @ 9:36 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00921375
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2009-05-23
Brief Title:
Safety and Efficacy of TULY Rasburicase in Prevention and Treatment of Malignancy-associated Hyperuricemia
Sponsor:
Virchow Group
Organization:
Virchow Group
Study Overview
Official Title:
Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
Status:
COMPLETED
Status Verified Date:
2014-12
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:
This study is a prospective open-label multicentre study Hundred eligible patients with stage III or IV non-Hodgkin lymphoma NHL or acute lymphoblastic leukemia ALL with a peripheral white blood cell WBC count of 25000µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mgdL will be treated with rasburicase 020 mgkg body weight intravenously for 4 days The primary endpoints viz the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period
Detailed Description:
All eligible patients will be treated with rasburicase 020 mgkg body weight intravenously for 4 days The primary endpoints viz the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VB037 | OTHER | Protocol Number | None |