Rasburicase in Tumor Lysis Syndrome

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hyperuricemia

Treatments: Drug: Rasburicase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00302653

L_9436

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: Rasburicase