5 results
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…
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…
The main objective is to assess the efficacy of the closed loop system at the home of the patient. Secondary objectives are to assess the safety of the new prototype while the telemonitoring intensity is being reduced during the trial; 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…
The main objective of this study is to assess efficacy of the closed loop system in patients after total pancreatectomy. Secondary objectives are to assess the safety of the closed loop system; to determine the time that the control algorithm is…