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Rasburicase (Fasturtec) Registration Trial

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ClinicalTrials.gov Identifier: NCT00607152
Recruitment Status : Terminated (the patient enrollment is too difficult)
First Posted : February 5, 2008
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

Primary:

To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.

Secondary:

To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).


Condition or disease Intervention/treatment Phase
Hyperuricemia Drug: Rasburicase Drug: Allopurinol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies
Study Start Date : October 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
IV infusion at a dose level of 0.20mg/kg per day
 Drug: Rasburicase
0.20mg/kg per day IV
Active Comparator: 2
100mg tablets, administered orally, according to standard medical practice
 Drug: Allopurinol
100mg tablets


Outcome Measures
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Primary Outcome Measures :
  1. Mean plasma uric acid AUC0-96 [ Time Frame: 0hour, 4hour, 12 hour and q12h thereafter ]
  2. Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing) [ Time Frame: From administration of drug up to end of study ]
  3. Biochemistry, hematology, vital signs, physical examination, and adverse events [ Time Frame: From administration of drug up to end of study ]
  4. Proportion of patients developing hypertension requiring therapy [ Time Frame: From administration of drug up to end of study ]
  5. Assays for circulating antibodies [ Time Frame: From administration of drug up to end of study ]

Secondary Outcome Measures :
  1. Percentage reduction of plasma uric acid concentrations at T4h [ Time Frame: From administration of drug up to end of study ]
  2. Mean plasma uric acid concentrations [ Time Frame: At various timepoints ]
  3. Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL [ Time Frame: From administration of drug up to end of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At high risk of malignancy and/or chemotherapy-induced hyperuricemia
  • Performance status less than 3 on ECOG scale or more than 30% KPS scale
  • Uric acid concentrations ≥ 8.0mg/dL
  • Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia

Exclusion Criteria:

  • Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
  • Pregnancy or lactation
  • Prior treatment with Uricozyme or Rasburicase
  • Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
  • Treatment with Allopurinol within the seven days preceding study Day 1
  • History of significant atopic allergy problems or documented history of asthma
  • History of severe reaction to allopurinol
  • Known history of glucose-6-phosphate dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607152


Locations
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China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Jing Fu Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00607152    
Other Study ID Numbers: RASBU_L_00351
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Allopurinol
Rasburicase
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
 Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs