3 results
Approved WMOCompleted
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Approved WMOPending
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
Approved WMOCompleted
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…