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

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

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

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00563771

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Study Director: Choe Seong Choon Sanofi
  More Information 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
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gout Suppressants
Antirheumatic Agents processed this record on October 21, 2016