5 results
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
The objective of this study is to evaluate whether two different stent technologies (a self-expandable stent and a balloon-expandable stent) may be associated with different stent strut apposition and a variety of stent strut coverage with…
To evaluate the safety and effectiveness of the STENTYS Coronary Stent System in the treatment of de novo stenotic lesions in coronary arteries in subjects undergoing primary revascularization due to Acute ST Segment Elevation Myocardial Infarction…
The study will compare the overall survival (OS) between the MABp1 treated and placebo arms. Secondary endpoints will include change in lean body mass from screening to the cycle 5 assessment and change in quality of life.