Back to resultsRasburicase in Tumor Lysis Syndrome
Primary Purpose
Hyperuricemia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Rasburicase
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia
Eligibility Criteria
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.
Sites / Locations
- Sanofi-aventis administrative office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
Outcomes
Primary Outcome Measures
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Adverse events occurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00302653
Brief Title
Rasburicase in Tumor Lysis Syndrome
Official Title
Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
Intervention Type
Drug
Intervention Name(s)
Rasburicase
Intervention Description
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
Primary Outcome Measure Information:
Title
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Time Frame
24-48 hours after last dose of rasburicase
Title
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Time Frame
28 (+- 3) days after the last dose of rasburicase
Title
Adverse events occurrence
Time Frame
During the study
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima
Organizational Affiliation
Sanofi-aventis administrative office Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis administrative office
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Rasburicase in Tumor Lysis Syndrome
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