Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
- Pharmacokinetic parameters and anti-SR29142 antibodies
|Study Start Date:||April 2003|
|Study Completion Date:||June 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|