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

This study has been completed.

First Received: November 21, 2007 Last Updated: January 24, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00563771

Purpose

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	Intervention	Phase
Hyperuricemia	Drug: Rasburicase	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Rasburicase

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Enrollment:	38
Study Start Date:	March 2003
Study Completion Date:	January 2004

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563771

Locations

Korea, Republic of
Sanofi-aventis
Seoul, Korea, Republic of

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Choe Seong Choon

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	L_8720
Study First Received:	November 21, 2007
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00563771 History of Changes
Health Authority:	Korea: Asan Medical Center

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Hyperuricemia
Tumor Lysis Syndrome

Antirheumatic Agents
Lymphoproliferative Disorders
Rasburicase

Additional relevant MeSH terms:

Lymphatic Diseases
Pathologic Processes
Immunoproliferative Disorders
Immune System Diseases
Therapeutic Uses
Hyperuricemia

Tumor Lysis Syndrome
Antirheumatic Agents
Lymphoproliferative Disorders
Gout Suppressants
Rasburicase
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 06, 2009