Status:
COMPLETED
Fasturtec TLS Treatment / Prophylysis
Lead Sponsor:
Sanofi
Conditions:
Tumor Lysis Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
Eligibility Criteria
Inclusion
- Chemotherapy planned for at least 3 cycles
- Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
- With a minimum life expectancy of 3 months
- Uric acid \> 8 mg%
- Negative pregnancy test \< or =to 2 weeks and efficient contraceptive method.
- Negative HIV serology \< or =to 4 weeks
- Patient or legal guardian has signed a written informed consent
Exclusion
- Hypersensitivity to uricases or any of the excipients
- Known history of G6PD deficiency.
- Previous treatment with Rasburicase or Uricozyme®
- Pregnancy or lactation
- Treatment with any investigational drug within 30 days before planned first Rasburicase administration
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00651911
Start Date
July 1 2003
End Date
July 1 2004
Last Update
April 3 2008
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807