3 results
Approved WMOCompleted
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…
Approved WMOCompleted
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…
Approved WMOCompleted
To determine the relative bioavailability of pramipexole 4.5 mg tablets vs. 4.5 mg Sifrol in healthy subjects after up-titration.