Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
This study has been completed.
Information provided by:
First received: November 21, 2007
Last updated: January 24, 2008
Last verified: January 2008
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
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
Primary Outcome Measures:
- Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||up to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00563771
|Seoul, Korea, Republic of |
||Choe Seong Choon
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 21, 2007
||January 24, 2008
||Korea: Asan Medical Center
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Tumor Lysis Syndrome
Immune System Diseases