9 results
The purpose of the study is research. The study investigates to what extent ANF Rho is tolerated in comparison to Neulasta® (representing standard of care treatment) and placebo. A placebo is the same formulation as the study medication without the…
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…
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
To decrease the cumulative incidence of (hematological) relapse
Objectives. The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and, in particular, of projects designed to discern new models for the successful conduct of clinical trials in…
Objectives: - to increase the proportion of patients with non-severe GVHD within 180 days post-allo-SCT - to reduce the progression rate - to improve the progression free survival- to asses the impact on the quality of life using a time restricted…
The purpose of the study is to compare LA-EP2006 and Neulasta®US and Neulasta®EU with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called…
To determine the ratio of parent drug to metabolites in the circulation.Profiling of [14C]-etripamil metabolites in blood, urine and feces.To determine the mass balance of drug-related materials following intranasal administration.To determine the…
The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF.