Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
All eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously
for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at
4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of
adverse events will be assessed during 11 days study period.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period
Yes
Dr. Raghunadharao D
Principal Investigator
NIMS
India: Drugs Controller General of India
VB037/2007
NCT00921375
June 2009
December 2009
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