Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
Phase 4
N/A
18 Years
N/A
18 Years
Not Enrolling
Both
Hyperuricemia
Both
Hyperuricemia
Trial Information
Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
Principal Investigator
Choe Seong Choon
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Korea: Asan Medical Center
Study ID:
L_8720
NCT ID:
NCT00563771
Start Date:
March 2003
Completion Date:
January 2004
Related Keywords:
- Hyperuricemia
- Tumor Lysis Syndrome
- Hyperuricemia
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