8 results
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
The primary objective is to determine the effect of intravenously administered rhAPC on HDM-LPS induced allergic lung inflammation.
The primary objective is to determine the effect of locally administered rhAPC on LPS-induced lung inflammation and coagulation. By using measurements on cells harvested from bronchoalveolar lavage (BAL)-fluid and in BAL-fluid supernatants, we will…
To demonstrate that treatment with drotrecogin alfa (activated) 24 mcg/kg/h administered as an intravenous infusion for 96 hours reduces 28 day all-cause mortality in adult patients with septic shock compared with placebo.
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
The primary objective is to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Secondary objectives…
The present study is aimed at identifying the specific routes of plitidepsin excretion and elimination following its administration to patients with advanced tumors. Also, the study design may allow the identification and quantification, if possible…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.