7 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: to explore the prevalence of urinary concentration defects (NDI) in a Dutch population of lithium treated patients.Secondary Objectives: to determine the relation of the dDAVP test results with complaints (micturition history) and…
To explore the safety, tolerability and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia.
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 primary objective of this study is to evaluate the short term safety and tolerability, and pharmacokinetic properties of 2-IB when administered to adult patients after OHCA. Secondary objectives include safety and efficacy parameters at 30 days…
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…
This study will be a prospective, placebo controlled, randomised phase 2 single centre study with the primary objective to evaluate the safety and tolerability of 2-IB when administered to patients with AIS due to LVO, treated with IVT and/or EVT.…