Primary Objective: To evaluate safety of rasburicase in pediatric patients with NHL and AL Secondary Objective: To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
Study duration per participants is approximatively 14 days including a 5-day treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pharmaceutical form:solution for infusion Route of administration: intravenous
investigational site CHINA
China, China
Incidence of AEs and SAEs
Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.
Time frame: Day 1 to Day 7
Number of responders after completion of rasburicase treatment under chemotherapy
Response will be defined as achievement of normal uric acid levels (≤ 8.0 mg/dL) in those patients whose uric acid levels are \>8.0 mg/dL.
Time frame: Day 1 to Day 7
Proportion of patients who can maintain the normal uric acid levels throughout the study
In those patients whose baseline plasma uric acid levels are ≤ 8 mg/dL but with a high risk of TLS.
Time frame: Day 1 to Day 7
Percentage of the maximum decreasing degree of plasma uric acid level from baseline
Time frame: Day 1 to Day 7
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