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Rasburicase in Tumor Lysis Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302653
First Posted: March 14, 2006
Last Update Posted: September 25, 2009
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
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

  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

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
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): 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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00302653     History of Changes
Other Study ID Numbers: L_9436
First Submitted: March 10, 2006
First Posted: March 14, 2006
Last Update Posted: September 25, 2009
Last Verified: September 2009

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