4 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…
Objectives: The following trial objectives for adolescent patients (from 12 and up to 18 years of age) with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:* Assess the effect of eculizumab on TMA-Event Free status…
Objectives: The following trial objectives for adult patients with plasma therapy-resistantAtypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:• Assess the effect of eculizumab to reduce thrombotic microangiopathy (TMA) asindicated by…