Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
Phase 4
N/A
18 Years
N/A
18 Years
Not Enrolling
Both
Hyperuricemia
Both
Hyperuricemia
Trial Information
Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Outcome Time Frame:
24-48 hours after last dose of rasburicase
Safety Issue:
No
Principal Investigator
Jaderson Lima
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi-aventis administrative office Brazil
Authority:
Brazil: National Health Surveillance Agency
Study ID:
L_9436
NCT ID:
NCT00302653
Start Date:
February 2006
Completion Date:
Related Keywords:
- Hyperuricemia
- Tumor Lysis Syndrome
- Hyperuricemia
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