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
  Purpose

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 Intervention Phase
Hyperuricemia
Drug: Rasburicase
Drug: Allopurinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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: NCT00607152

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jing Fu Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00607152     History of Changes
Other Study ID Numbers: RASBU_L_00351
Study First Received: January 22, 2008
Last Updated: May 7, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes
Rasburicase
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014