Rasburicase in Tumor Lysis Syndrome

Hyperuricemia Clinical Trial

Official title:

Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302653
• Other study ID #: L_9436
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2006
• Last updated: September 24, 2009
• Start date: February 2006

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia
• Tumor Lysis Syndrome

Intervention

Drug:
• Rasburicase
Rasburicase 0,20mg/Kg/Day once a day 3-7 days

Locations

Country	Name	City	State
Brazil	Sanofi-aventis administrative office	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)		24-48 hours after last dose of rasburicase	No
Primary	Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)		28 (+- 3) days after the last dose of rasburicase	No
Primary	Adverse events occurrence		During the study	Yes