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| Sponsor: | 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: | Intervention Model: Single Group Assignment Masking: 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 |
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00563771 History of Changes |
| Other Study ID Numbers: | L_8720 |
| Study First Received: | November 21, 2007 |
| Last Updated: | January 24, 2008 |
| Health Authority: | Korea: Asan Medical Center |
|
Tumor Lysis Syndrome Hyperuricemia Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Pathologic Processes Rasburicase Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |