Rasburicase (Fasturtec) Registration Trial

Hyperuricemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607152
• Other study ID #: RASBU_L_00351
• Status: Terminated
• Phase: Phase 3
• First received: January 22, 2008
• Last updated: May 7, 2014
• Start date: October 2007
• Est. completion date: January 2009

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 ).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• Rasburicase
0.20mg/kg per day IV
• Allopurinol
100mg tablets

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean plasma uric acid AUC0-96		0hour, 4hour, 12 hour and q12h thereafter	No
Primary	Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)		From administration of drug up to end of study	No
Primary	Biochemistry, hematology, vital signs, physical examination, and adverse events		From administration of drug up to end of study	No
Primary	Proportion of patients developing hypertension requiring therapy		From administration of drug up to end of study	No
Primary	Assays for circulating antibodies		From administration of drug up to end of study	No
Secondary	Percentage reduction of plasma uric acid concentrations at T4h		From administration of drug up to end of study	No
Secondary	Mean plasma uric acid concentrations		At various timepoints	No
Secondary	Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL		From administration of drug up to end of study	No