Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Sanofi38 enrolled

Overview

To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperuricemia

Interventions

RasburicaseDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL ) * With a minimum life expectancy of 3 months * Having previously signed a written informed consent. Exclusion Criteria: * Hypersensitivity to uricase or any of the excipients. * Known history of G6PD deficiency. * Previous treatment with Rasburicase or Uricozyme. * Treatment with any investigational drug within 30 days before planned first Rasburicase administration. 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

Seoul, South Korea

Outcomes

Primary Outcomes

Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)

Data from ClinicalTrials.gov

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