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Fasturtec TLS Treatment / Prophylysis

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00651911
First received: March 28, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Tumor Lysis Syndrome
Drug: urate oxidase
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: July 2003
Study Completion Date: July 2004
Intervention Details:
    Drug: urate oxidase
    First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.
    Other Name: rasburicase
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651911

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sharon Chang Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00651911     History of Changes
Other Study ID Numbers: L_8637
Study First Received: March 28, 2008
Last Updated: March 31, 2008
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Syndrome
Tumor Lysis Syndrome
Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Pathologic Processes
Rasburicase
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014