Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome - Full Text View

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

This study has been completed.

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

MedlinePlus related topics:

Cancer

Drug Information available for:

Rasburicase

U.S. FDA Resources

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

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

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Hyperuricemia

Tumor Lysis Syndrome

Lymphoproliferative Disorders

Rasburicase

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Therapeutic Uses

Antirheumatic Agents

Gout Suppressants

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008