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…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
This study will be conducted to determine the overall hr-HPV agreement between self-sampled cervicovaginal smear (Evalyn Brush) and physician-obtained samples taken by a trained physician (liquid based cervical smear) in a screening population. The…
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*…
Study Objectives:The purpose of this Phase 2 study is to evaluate the safety, efficacy, pharmacokinetics (PK),pharmacodynamics (PD), and immunogenicity of narsoplimab in paediatric-aged patients withthrombotic microangiopathies (TMA) following…