5 results
To measure the effectiveness of intrathecal methylprednisolone and lidocaine on reducing PHN. Measurement of mthylprednisolone concentrations in cerebrospinal fluid (Part I only).
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…
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 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…
To investigate the reliability and feasibility of PK-guided prophylactic dosing of factor concentrates in hemophilia A and B patients (predictive performance).