Rasburicase in Tumor Lysis Syndrome

Phase 4

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: Rasburicase

• Registration Number: NCT00302653
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-10
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-14
• Primary Completion: 2006-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-24
• Last Update Posted: 2009-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Rasburicase	Rasburicase 0,20mg/Kg/Day once a day 3-7 days

Primary Outcome Measures

Name	Time	Method
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)	28 (+- 3) days after the last dose of rasburicase
Adverse events occurrence	During the study

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇧🇷 São Paulo, Brazil