17 results
The objective of the study is to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.
The objective of this pilot study is to investigate the feasibility of using the Clip system in a human setting in creating an intracranial arteriotomy in a non-occlusive, sutureless fashion. Although the focus is on the technical success of the…
Assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Part 1 - To determine the efficacy of oral BCX9930 monotherapy administered for 24 weeks, compared to continued complement component 5 (C5) inhibitor therapy, in subjects with paroxysmal nocturnal hemoglobinuria (PNH) with an inadequate response to…
The aim of this study is to determine whether LNP023 is effective and safe for the treatment of PNH. LNP023 is compared to the Standard of Care (SOC) anti-C5 antibody treatment. The primary objectives are to:• Demonstrate superiority of LNP023…
The objective of this explorative study is to determine the feasibility of measuring dEMG with a belt in preterm and term born infants during routine caregiving. Feasibility is confirmed when heart rate and respiratory rate reach a predefined level…
This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.
Primary Objective: The primary objective for this study is to evaluate the efficacy of ABP 959 compared with that of eculizumab based on control of intravascular hemolysis.Secondary Objective: The secondary objective is to assess the safety,…
Efficacy of ALXN1210Sub-study: to Evaluate Patient Preference for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
To establish equivalence (non-inferiority) between monitoring performance of the Bambi Belt and the currently used cardio-respiratory monitoring device. The Bambi Belt is a potentially more patient friendly, wireless cardio-respiratory monitoring…
The primary objectives of this study are to establish the efficacy and safety of APL-2 compared to eculizumab in patients with PNH who continue to have Hb levels <10.5 g/dL despite treatment with eculizumab.
The primary objective of this study is to assess the noninferiority of ALXN1210 compared to eculizumab in adult patients with PNH who have never been treated with a complement inhibitor. Noninferiority will be claimed if after 26 weeks of treatment…
To evaluate the efficacy of crovalimab compared to eculizumab
Demonstrate the suitability of cardiorespiratory monitoring directly after birth using a novel, wireless, non-adhesive device.
To evaluate the safety and tolerability of crovalimab compared witheculizumab
The primary objectiveTo evaluate the efficacy of eculizumab in the treatment of pediatric refractory generalized myasthenia gravis (gMG) based on change from Baseline in the Quantitative Myasthenia Gravis score for disease severity (QMG).The…