6 results
The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of asciminib in pediatric patients, with the goal of identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in…
To assess whether an adequate response to pneumococcal antigen, as a marker of overall humoral immune system reactivity, predicts sustained TFR. An adequate response to pneumococcal antigen will be defined as achieving anti-pneumococcal IgG levels…
The purpose of this study is to investigate the effect of the study compound efgartigimod on the immune system's response to vaccination with Pneumovax 23. We also investigate how safe efgartigimod is and how well it is tolerated when it is…
Primary:To assess the tolerability of asciminib versus nilotinib with respect to the time to discontinuation of study treatment due to adverse event.Secondary:• Efficacy of asciminib versus nilotinib in terms of discontinuation due to lack of…
Primary Objective: • To develop new criteria for the interpretation of the IgG response to pneumococcal polysaccharide vaccination using serotype-specific normal values.Secondary Objectives: • To develop criteria for the interpretation of the IgG1,…