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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
History of Changes
  Purpose

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


Condition Intervention Phase
Hyperuricemia
 Drug: Rasburicase
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Rasburicase
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)

Enrollment: 38
Study Start Date: March 2003
Study Completion Date: January 2004
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563771

Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Choe Seong Choon Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00563771     History of Changes
Other Study ID Numbers: L_8720
Study First Received: November 21, 2007
Last Updated: January 24, 2008
Health Authority: Korea: Asan Medical Center

Additional relevant MeSH terms:
Tumor Lysis Syndrome
Hyperuricemia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013