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Rasburicase (Fasturtec) Registration Trial

This study has been terminated.
(the patient enrollment is too difficult)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00607152
First received: January 22, 2008
Last updated: May 7, 2014
Last verified: May 2014

January 22, 2008
May 7, 2014
October 2007
January 2009   (final data collection date for primary outcome measure)
  • Mean plasma uric acid AUC0-96 [ Time Frame: 0hour, 4hour, 12 hour and q12h thereafter ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Biochemistry, hematology, vital signs, physical examination, and adverse events [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
  • Proportion of patients developing hypertension requiring therapy [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
  • Assays for circulating antibodies [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00607152 on ClinicalTrials.gov Archive Site
  • Percentage reduction of plasma uric acid concentrations at T4h [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
  • Mean plasma uric acid concentrations [ Time Frame: At various timepoints ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rasburicase (Fasturtec) Registration Trial
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

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 ).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperuricemia
  • Drug: Rasburicase
    0.20mg/kg per day IV
  • Drug: Allopurinol
    100mg tablets
  • Experimental: 1
    IV infusion at a dose level of 0.20mg/kg per day
    Intervention: Drug: Rasburicase
  • Active Comparator: 2
    100mg tablets, administered orally, according to standard medical practice
    Intervention: Drug: Allopurinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2009
January 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00607152
RASBU_L_00351
No
Sanofi
Sanofi
Not Provided
Study Director: Jing Fu Sanofi
Sanofi
May 2014

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