Rasburicase (Fasturtec) Registration Trial
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperuricemia
Intervention: Rasburicase (Drug); Allopurinol (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Jing Fu, Study Director, Affiliation: Sanofi
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 and safety of Rasburicase versus allopurinol in Chinese patients
stratified according to disease (leukemia or lymphoma ).
Clinical Details
Official title: A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean plasma uric acid AUC0-96Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing) Biochemistry, hematology, vital signs, physical examination, and adverse events Proportion of patients developing hypertension requiring therapy Assays for circulating antibodies
Secondary outcome: Percentage reduction of plasma uric acid concentrations at T4hMean plasma uric acid concentrations Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Shanghai, China
Additional Information
Starting date: October 2007
Last updated: May 7, 2014
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