Fasturtec TLS Treatment / Prophylysis
Phase 4
Completed
- Conditions
- Tumor Lysis Syndrome
- Registration Number
- NCT00651911
- Lead Sponsor
- Sanofi
- Brief Summary
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the uricolytic response to rasburicase treatment 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
- Secondary Outcome Measures
Name Time Method To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
Trial Locations
- Locations (1)
Sanofi-Aventis
🇺🇸Bridgewater, New Jersey, United States