Fasturtec TLS Treatment / Prophylysis

Completed · Phase 4

Conditions studied: Tumor Lysis Syndrome

In brief

An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome

Key facts

Study ID

NCT00651911

Run by

Sanofi

People needed

45

Starts

2003-07-01

Expected to finish

2004-07-01

Last updated by the study team

2008-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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