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Fasturtec TLS Treatment / Prophylysis

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
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

Official(s) and/or principal investigator(s):
Sharon Chang, Study Director, Affiliation: Sanofi

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Starting date: July 2003
Last updated: March 31, 2008

Page last updated: August 20, 2015

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