Kurzfassung

A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY 86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B).
Part A: Sequential cohorts of four dose levels of the modified rFVIIa BAY 86-6150 assessed
in a non-controlled dose response design in acutely bleeding subjects and for PK/ PD in an
intra-individual crossover design compared with one fixed dose of eptacog alfa (activated) in
non-bleeding subjects.
Part B:...A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY 86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B).
Part A: Sequential cohorts of four dose levels of the modified rFVIIa BAY 86-6150 assessed
in a non-controlled dose response design in acutely bleeding subjects and for PK/ PD in an
intra-individual crossover design compared with one fixed dose of eptacog alfa (activated) in
non-bleeding subjects.
Part B: Confirmatory study to further investigate the efficacy and
safety of BAY 86-6150.
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