Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to
immunosuppression susceptible to infections, including fungal infections. As the failure
rate in the treatment of invasive fungal infections is high, prophylaxis is frequently
recommended. This open label study investigates the safety and tolerability of two different
dosages of a water soluble azole antifungal, as well as the efficacy in prevention of
invasive fungal infections and pharmacokinetic data.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)
Up to Day 28
No
Oliver Cornely, MD
Principal Investigator
University of Cologne, Germany
Germany: Federal Institute for Drugs and Medical Devices
WSA-CS-002
NCT00413439
May 2006
June 2007
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