6 results
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
Primary objective The primary objective of the study is the evaluation of the therapeutic benefit of three repeated dose intratympanic AM 101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute…
Primary Objective:The primary objective of the study is to determine the safety including immunogenicity of BAX 855 based on the incidence of inhibitor development to FVIII (* 0.6 Bethesda unit (BU)/mL using the Nijmegen modification of the Bethesda…
Phase 1:The primary objective of this trial is to investigate whether oral esketamine is non-inferior to ECT after eight weeks of individually optimized treatment, in participants with NTRD.Phase 2:To compare the efficacy of maintenance oral…
Study Purpose* To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the prevention and treatment of bleeding episodes in PTPs (children and adults from 0 to 75 years of age) with severe hemophilia A.Primary…
To investigate whether oral esketamine is non-inferior to ECT in achieving treatment response on depression severity in NTRD.