21 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…
The purpose of the study is to investigate how quickly and to what extent S 38844 and S 41015 are absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Also the involvement of a specific…
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…
Primary:to evaluate the safety and tolerability of single dose administration of the study drug in healthy male subjectsto determine the pharmacokinetic parameters following single dose administration of the study drug in healthy male subjectso…
The primary endopoint is to determine whether ketoconazole/octreotide combination therapy, followed by octreotide monotherapy, is an effective treatment for Cushing's disease. Secundary endpoints address the effects of this therapy on bone…
The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…
The objective of the study is to improve medical treatment of Cushing's disease by combining partially independent medical therapies which act through differential mechanisms. Given the high affinity of SOM230 to sst5 and considering the facts…
Primary:To determine the effects of multiple-dose ketoconazole (Keto) on the pharmacokinetics of single-dose oral LBH589 in patients with advanced solid tumors.Secondary:In cancer patients with advanced solid tumors:* To assess the pharmacokinetic…
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.
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…
Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.
Primary objective: To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, in a therapeutic dose on the plasma pharmacokinetics (PK) of eribulin administered via intravenous (IV) infusion.Secondary…
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.
This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.
To evaluate the safety and tolerability of crovalimab compared witheculizumab
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…
Efficacy of ALXN1210Sub-study: to Evaluate Patient Preference for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
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,…
To evaluate the efficacy of crovalimab compared to eculizumab