Status:
TERMINATED
Rasburicase (Fasturtec) Registration Trial
Lead Sponsor:
Sanofi
Conditions:
Hyperuricemia
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- At high risk of malignancy and/or chemotherapy-induced hyperuricemia
- Performance status less than 3 on ECOG scale or more than 30% KPS scale
- Uric acid concentrations ≥ 8.0mg/dL
- Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia
Exclusion
- Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
- Pregnancy or lactation
- Prior treatment with Uricozyme or Rasburicase
- Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
- Treatment with Allopurinol within the seven days preceding study Day 1
- History of significant atopic allergy problems or documented history of asthma
- History of severe reaction to allopurinol
- Known history of glucose-6-phosphate dehydrogenase deficiency.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00607152
Start Date
October 1 2007
End Date
January 1 2009
Last Update
May 8 2014
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Shanghai, China