Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
|ClinicalTrials.gov Identifier: NCT00631579|
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : October 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperuricemia Leukemia Lymphoma||Drug: Rasburicase (SR29142)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2003|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||June 2004|
- Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
- Pharmacokinetic parameters and anti-SR29142 antibodies
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631579