20 results
Main Objective:Assess the efficacy of eculizumab as compared with placebo in the treatment of refractory gMG based on the improvement in the MG specific Activities of Daily Living profile (MG-ADL).Secondary Objectives: - Safety and tolerability of…
We hypothesized that obliteration of the dead space following mastectomy would significantly reduce seroma formation and therefore seroma related wound complications and patient discomfort (fewer seroma aspirations and fewer check ups in the out…
In subjects with T2DM with inadequate glycemic control on combination therapy withmetformin and an SU:Primary:* To assess the effect of the addition of treatment with canagliflozin compared with theaddition of treatment with sitagliptin on HbA1c…
In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…
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.
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.
Primary objectiveIn subjects with T2DM receiving standard of care but with inadequate glycemic control and at elevatedrisk of cardiovascular (CV) events to assess the effect of canagliflozin compared to placebo onprogression of albuminuria.Secondary…
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,…
This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.
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…
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…
Efficacy of ALXN1210Sub-study: to Evaluate Patient Preference for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
The main objectives are:• To assess canagliflozin target (i.e. receptor) specific binding in vivo• To assess receptor occupancy of canagliflozin in vivo• To determine optimal scanning time in vivoTo explore the relationship between canagliflozin…
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.
To evaluate the efficacy of crovalimab compared to eculizumab
To evaluate if hepcidin levels can predict response to iron therapy with either ferrous fumarate, ferric maltol, and intravenous iron in patients with IBD.
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…
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…