5 results
Primary ObjectiveThe primary objective is to compare the annualized rates of bleeding episodes (ABR)between subjects receiving a prophylactic regimen of BAX 855 with an on-demandtreatment regimen.Secondary ObjectivesThe key secondary objective is to…
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…
Effect on bone mineral density.
This study consists of the following objections:- To evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham)- To evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared…
To assess the efficacy of Revita® DMR for improving HbA1c to <= 7% without the need of insulin in subjects with T2D compared to sham.To assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.