Rasburicase in Tumor Lysis Syndrome

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 10, 2006
Last updated: September 24, 2009
Last verified: September 2009

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

Condition Intervention Phase
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:

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


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

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

Sanofi-aventis administrative office
São Paulo, Brazil
Sponsors and Collaborators
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
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014