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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hyperuricemia

Treatments: Drug: Rasburicase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563771

L_8720

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)