Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
Phase 4
Completed
- Conditions
- Hyperuricemia
- Registration Number
- NCT00563771
- Lead Sponsor
- Sanofi
- Brief Summary
To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
-
Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )
- With a minimum life expectancy of 3 months
- Having previously signed a written informed consent.
Exclusion Criteria
- Hypersensitivity to uricase or any of the excipients.
- Known history of G6PD deficiency.
- Previous treatment with Rasburicase or Uricozyme.
- Treatment with any investigational drug within 30 days before planned first Rasburicase administration.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇰🇷Seoul, Korea, Republic of