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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00563771
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Duration (Months): 10.1
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: Rasburicase	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
• Study Start Date: Mar 1, 2003
• Actual Study Completion Date: Jan 1, 2004

Outcome Measures

Primary Outcome Measures

1. Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Seoul		Korea, Republic of

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Choe Seong Choon, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563771
• Other Study ID Numbers: L_8720
• First Posted: Nov 26, 2007
• Last Update Posted: Jan 28, 2008
• Last Verified: Jan 1, 2008

• Additional relevant MeSH terms: Tumor Lysis Syndrome; Hyperuricemia; Rasburicase

Study Results

No Results Posted as of Jan 28, 2008