Rasburicase in Tumor Lysis Syndrome

Phase 4CompletedNCT00302653

Sanofi33 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperuricemia

Interventions

RasburicaseDRUG

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-aventis administrative office

São Paulo, Brazil

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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