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Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome


Phase 2
N/A
17 Years
Not Enrolling
Both
Nutritional and Metabolic Diseases

Thank you

Trial Information

Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Keiji OHNO

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ACT5080

NCT ID:

NCT00290992

Start Date:

June 2005

Completion Date:

April 2006

Related Keywords:

  • Nutritional and Metabolic Diseases
  • urate oxidase, hyperuricemia, lymphoma, leukemia
  • Metabolic Diseases
  • Tumor Lysis Syndrome
  • Hyperuricemia

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