Rasburicase in Tumor Lysis Syndrome
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00302653
Collaborator
(none)
33
1
1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
33 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
Study Start Date
:
Feb 1, 2006
Actual Primary Completion Date
:
Nov 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Rasburicase 0,20mg/Kg/Day once a day 3-7 days |
Drug: Rasburicase
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) [24-48 hours after last dose of rasburicase]
- Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) [28 (+- 3) days after the last dose of rasburicase]
- Adverse events occurrence [During the study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
List of inclusion Criteria:
- Acute hyperuricemia patients(uric acid>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.
List of exclusion Criteria:
-
Hypersensitivity to uricases or any of the excipients.
-
Known history of hemolytic anemia (G6PD deficiency).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-aventis administrative office | São Paulo | Brazil |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Jaderson Lima, Sanofi-aventis administrative office Brazil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00302653
Other Study ID Numbers:
- L_9436
First Posted:
Mar 14, 2006
Last Update Posted:
Sep 25, 2009
Last Verified:
Sep 1, 2009