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

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

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Key information

Conditions

Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rasburicase

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Important dates

Study start: 2003
Study completion: 2004
First posted: Nov 26, 2007
Registry last updated: Jan 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed