5 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 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*…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
This trial is intended to evaluate the safety and effectiveness of St. Jude Medical*s AMPLATZERTM AmuletTM device (Amulet) in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism. The trial will…
PART I:Primary:• To investigate the safety and tolerability of two doses of VAD044 administered daily for up to 12 weeks in HHT patients.Secondary:• To assess the effects of two doses of VAD044 for up to 12 weeks of treatment on:o Epistaxis:•…