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Rasburicase for Hyperuricemia
This study has been completed.
Study NCT00290992   Information provided by Sanofi-Aventis
First Received: February 10, 2006   Last Updated: March 27, 2009   History of Changes

February 10, 2006
March 27, 2009
June 2005
April 2006   (final data collection date for primary 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.
- 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.
Complete list of historical versions of study NCT00290992 on ClinicalTrials.gov Archive Site
  • Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
  • G6PD activity will be measured in only patients who demonstrate hemolysis.
  • Anti-SR29142 antibody and Anti-SCP antibody will be measured.
  • PK parameters.
  • - Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
  • - G6PD activity will be measured in only patients who demonstrate hemolysis.
  • - Anti-SR29142 antibody and Anti-SCP antibody will be measured.
  • - PK parameters.
 
Rasburicase for Hyperuricemia
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

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.

 
Phase II
Interventional
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment
Nutritional and Metabolic Diseases
Drug: rasburicase (SR29142)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
April 2006
April 2006   (final data collection date for primary outcome measure)

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.
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00290992
Study director, sanofi-aventis
ACT5080
Sanofi-Aventis
 
Study Director: Keiji OHNO Sanofi-Aventis
Sanofi-Aventis
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP