Fasturtec TLS Treatment / Prophylysis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2008

Last Updated Date

March 31, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To assess the uricolytic response to rasburicase treatment [ Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00651911 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Fasturtec TLS Treatment / Prophylysis

Official Title ^ICMJE

A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Tumor Lysis Syndrome

Intervention ^ICMJE

Drug: urate oxidase

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00651911

Responsible Party

Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

L_8637

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sharon Chang

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP