Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT00290992
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT00290992
Study Brief:
Protocol Section:
NCT00290992