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

Hyperuricemia Clinical Trial

Official title:

Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563771
• Other study ID #: L_8720
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2007
• Last updated: January 24, 2008
• Start date: March 2003
• Est. completion date: January 2004

Study information

• Verified date: January 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Asan Medical Center
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia
• Tumor Lysis Syndrome

Intervention

Drug:
• Rasburicase

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)