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Completed

NCT Number: NCT00302653

Rasburicase in Tumor Lysis Syndrome

The purpose of this study is to determine whether rasburicase is effective and safety in correcting 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 administrative office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Rasburicase

Drug

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

Primary outcomes

  1. Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)

    Time frame: 24-48 hours after last dose of rasburicase

  2. Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)

    Time frame: 28 (+- 3) days after the last dose of rasburicase

  3. Adverse events occurrence

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
First posted
Mar 14, 2006
Registry last updated
Sep 25, 2009

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.

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