Clinical trial NCT00607152: Rasburicase (Fasturtec) Registration 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hyperuricemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ).


Eligibility 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.

Primary outcomes:
measure: Mean plasma uric acid AUC0-96
timeFrame: 0hour, 4hour, 12 hour and q12h thereafter
measure: Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)
timeFrame: From administration of drug up to end of study
measure: Biochemistry, hematology, vital signs, physical examination, and adverse events
timeFrame: From administration of drug up to end of study
measure: Proportion of patients developing hypertension requiring therapy
timeFrame: From administration of drug up to end of study
measure: Assays for circulating antibodies
timeFrame: From administration of drug up to end of study
Secondary outcomes:
measure: Percentage reduction of plasma uric acid concentrations at T4h
timeFrame: From administration of drug up to end of study
measure: Mean plasma uric acid concentrations
timeFrame: At various timepoints
measure: Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL
timeFrame: From administration of drug up to end of study
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jing Fu
role: STUDY_DIRECTOR
References: