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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563771
First Posted: November 26, 2007
Last Update Posted: January 28, 2008
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.
Information provided by:
Sanofi
  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: None (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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): NCT00563771


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

ClinicalTrials.gov Identifier: NCT00563771     History of Changes
Other Study ID Numbers: L_8720
First Submitted: November 21, 2007
First Posted: November 26, 2007
Last Update Posted: January 28, 2008
Last Verified: January 2008

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