Rasburicase for Hyperuricemia
Nutritional and Metabolic Diseases
About this trial
This is an interventional treatment trial for Nutritional and Metabolic Diseases focused on measuring urate oxidase, hyperuricemia, lymphoma, leukemia
Eligibility Criteria
Inclusion Criteria: <18 years of age Patient with newly diagnosed hematological malignancies presenting with hyperuricemia: Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13 years old Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined: Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level, Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following: At least one lymph node or mass >5 cm in diameter LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc. Exclusion Criteria: Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period. Low birth weight infant (<2500g) or gestational age <37 weeks Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period. Known history of severe allergic reaction and/or severe asthma. Known history or family history of glucose-6-phosphate dehydrogenase deficiency. Known history of hemolysis and methemoglobinemia. Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x ULN, Creatinine > 3.0 x ULN Uncontrollable infections (including viral infections). Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.
Sites / Locations
- Sanofi-Aventis