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Rasburicase in Tumor Lysis Syndrome

This study has been completed.
Information provided by:
Sanofi 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
Hyperuricemia Drug: Rasburicase Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) [ Time Frame: 28 (+- 3) days after the last dose of rasburicase ]
  • Adverse events occurrence [ Time Frame: During the study ]

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   (Child, Adult)
Sexes Eligible for Study:   All
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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00302653

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

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00302653     History of Changes
Other Study ID Numbers: L_9436
Study First Received: March 10, 2006
Last Updated: September 24, 2009

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 August 23, 2017