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Rasburicase for Hyperuricemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00290992
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : March 30, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Nutritional and Metabolic Diseases Drug: rasburicase (SR29142) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rasburicase
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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.

Secondary Outcome Measures :
  1. Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
  2. G6PD activity will be measured in only patients who demonstrate hemolysis.
  3. Anti-SR29142 antibody and Anti-SCP antibody will be measured.
  4. PK parameters.

Eligibility Criteria

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290992


Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Keiji OHNO Sanofi
More Information

Responsible Party: Study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00290992     History of Changes
Other Study ID Numbers: ACT5080
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
urate oxidase, hyperuricemia, lymphoma, leukemia

Additional relevant MeSH terms:
Metabolic Diseases
Hyperuricemia
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents