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Rasburicase in Tumor Lysis Syndrome

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00302653
First received: March 10, 2006
Last updated: September 24, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.


Condition Intervention Phase
Hyperuricemia
 Drug: Rasburicase
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of 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:
  • Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) [ Time Frame: 24-48 hours after last dose of rasburicase ] [ Designated as safety issue: No ]
  • Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) [ Time Frame: 28 (+- 3) days after the last dose of rasburicase ] [ Designated as safety issue: No ]
  • Adverse events occurrence [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: February 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
 Drug: Rasburicase
Rasburicase 0,20mg/Kg/Day once a day 3-7 days

  Eligibility

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

List of inclusion Criteria:

  • Acute hyperuricemia patients(uric acid>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.

List of exclusion Criteria:

  • Hypersensitivity to uricases or any of the excipients.
  • Known history of hemolytic anemia (G6PD deficiency).

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: NCT00302653

Locations
Brazil
Sanofi-aventis administrative office
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00302653     History of Changes
Other Study ID Numbers: L_9436
Study First Received: March 10, 2006
Last Updated: September 24, 2009
Health Authority: Brazil: National Health Surveillance Agency

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 21, 2013