3 results
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…
- To compare the primary pharmacokinetic parameters AUC0-last, AUC0-*, and Cmax of MK-8228 after single dose administration of one tablet of 480 mg MK-8228 (test) and two tablets of 240 mg MK-8228 (reference) under fasting conditions.- To compare…