5 results
Primary objective:The primary objective is aimed at determining the comparability of intracardiac impedance (ICI) measurements to echocardiographic reference parameters in assessment of changes in stroke volume (SV) in an acute setting. It is…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…
The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of transcatheter based mitral repair in subjects with mitral regurgitation.