6 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
The primary objective of this randomized controlled trial is to investigate the efficacy of dashboard driven dosing of infliximab compared to standard dosing during the induction phase in patients with acute severe ulcerative colitis, as evaluated…
The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of transcatheter based mitral repair in subjects with mitral regurgitation.