Rasburicase for Hyperuricemia (NCT00290992) | Clinical Trial Compass
CompletedPhase 2
Rasburicase for Hyperuricemia
Japan30 participantsStarted 2005-06
Plain-language summary
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.
Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (inclu…
What they're measuring
1
Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.