Rasburicase in Tumor Lysis Syndrome

September 24, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
Drug: Rasburicase
Rasburicase 0,20mg/Kg/Day once a day 3-7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Time Frame: 24-48 hours after last dose of rasburicase
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
28 (+- 3) days after the last dose of rasburicase
Adverse events occurrence
Time Frame: During the study
During the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Jaderson Lima, Sanofi-aventis administrative office Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 14, 2006

Study Record Updates

Last Update Posted (Estimate)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9436

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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