Rasburicase in Tumor Lysis Syndrome

NCT ID: NCT00302653

Last Updated: 2009-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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

Detailed Description

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Conditions

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Hyperuricemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Rasburicase

Intervention Type DRUG

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

Interventions

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Rasburicase

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute hyperuricemia patients(uric acid\>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.

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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi-aventis administrative office Brazil

Locations

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Sanofi-aventis administrative office

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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L_9436

Identifier Type: -

Identifier Source: org_study_id

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