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the patient enrollment is too difficult
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Primary:
To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.
Secondary:
To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | IV infusion at a dose level of 0.20mg/kg per day |
|
| 2 | Active Comparator | 100mg tablets, administered orally, according to standard medical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasburicase | Drug | 0.20mg/kg per day IV |
| |
| Allopurinol |
| Measure | Description | Time Frame |
|---|---|---|
| Mean plasma uric acid AUC0-96 | 0hour, 4hour, 12 hour and q12h thereafter | |
| Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing) | From administration of drug up to end of study | |
| Biochemistry, hematology, vital signs, physical examination, and adverse events | From administration of drug up to end of study | |
| Proportion of patients developing hypertension requiring therapy | From administration of drug up to end of study | |
| Assays for circulating antibodies | From administration of drug up to end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction of plasma uric acid concentrations at T4h | From administration of drug up to end of study | |
| Mean plasma uric acid concentrations | At various timepoints | |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Jing Fu | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Shanghai | China |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C469709 | rasburicase |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
100mg tablets |
|
| Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL |
| From administration of drug up to end of study |