Rasburicase in Tumor Lysis Syndrome - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00302653

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 IV

MedlinePlus related topics: Cancer

Drug Information available for: Rasburicase

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.

Further study details as provided by Sanofi-Aventis:

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
1: Experimental 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

Criteria

List of inclusion Criteria:

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

List of exclusion Criteria:

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-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-aventis administrative office Brazil

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L_9436
Study First Received:	March 10, 2006
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00302653 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Hyperuricemia
Tumor Lysis Syndrome

Antirheumatic Agents
Lymphoproliferative Disorders
Rasburicase

Additional relevant MeSH terms:

Lymphatic Diseases
Pathologic Processes
Immunoproliferative Disorders
Immune System Diseases
Therapeutic Uses
Hyperuricemia

Tumor Lysis Syndrome
Antirheumatic Agents
Lymphoproliferative Disorders
Gout Suppressants
Rasburicase
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009