Fasturtec TLS Treatment / Prophylysis
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tumor Lysis Syndrome
Intervention: urate oxidase (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Sharon Chang, Study Director, Affiliation: Sanofi-Aventis
Summary
An open-label study to determine the efficacy and safety of Rasburicase used for the
prevention and treatment of tumor lysis syndrome
Clinical Details
Official title: A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To assess the uricolytic response to rasburicase treatment
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
clinicalstudyresults.org
Starting date: July 2003
Ending date: July 2004
Last updated: March 31, 2008
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