Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00563771
First received: November 21, 2007
Last updated: January 24, 2008
Last verified: January 2008

November 21, 2007
January 24, 2008
March 2003
Not Provided
Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
Same as current
Complete list of historical versions of study NCT00563771 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperuricemia
Drug: Rasburicase
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2004
Not Provided

Inclusion Criteria:

  • Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )

    • With a minimum life expectancy of 3 months
    • Having previously signed a written informed consent.

Exclusion Criteria:

  • Hypersensitivity to uricase or any of the excipients.
  • Known history of G6PD deficiency.
  • Previous treatment with Rasburicase or Uricozyme.
  • Treatment with any investigational drug within 30 days before planned first Rasburicase administration.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00563771
L_8720
No
Not Provided
Sanofi
Not Provided
Study Director: Choe Seong Choon Sanofi
Sanofi
January 2008

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