6 results
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 objective of the study is to test the effects of the p-glycoproteine transporter on cognitive test in healthy volunteers and to explore the effects of the p-glycoproteine transporter on functional Magnetic Resonance Imaging (fMRI).
To demonstrate that parallel infusion of saline added to the continous infusion of clotting factor concentrates prevents local thromboembolic complications to the same extent as heparin together with a parallel infusion of saline does.
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*…
Scar volume and POSAS score will be measured in the Verapamil group, these will be compared to the scar volume and POSAS score in the Kenacort+Verapamil group and the Kenacort group. In addition, complications/ adverse effects will be reported.
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.