Spots Global Cancer Trial Database for Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
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Trial Identification
Brief Title: Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Official Title: Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Study ID: NCT00631579
Interventions
Study Description
Brief Summary: The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups. Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis, Tokyo, , Japan
Contact Details
Name: K.K.
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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