Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects

Inclusion Criteria: * Male and female Japanese subjects greater than or equal to 20 years * Subjects currently on vitamin K antagonist (VKA) therapy * INR greater than or equal to 2 within 3 hours before start of BE1116 infusion * Urgent reversal of VKA therapy for a surgical or invasive medical procedure is required within 24 hours of the start of BE1116 infusion, or presentation with an acute major bleed Exclusion Criteria: * Subjects for whom administration of I.V. vitamin K and VKA withdrawal, alone, can adequately correct the subject's coagulopathy before the infusion of BE1116 * Subjects in whom lowering the INR to within the normal range is not a treatment goal * Use of anticoagulants other than VKAs (or expected use within 1 day) * Medical history for which PCCs are contraindicated * History of thromboembolic event within 3 months of screening * Congenital or acquired abnormality of hemostasis other than receipt of VKAs * Administration of whole blood, plasma, plasma fractions, or platelets within 2 weeks prior to the start of BE1116 infusion * For subjects with intracranial hemorrhage (ICH): * Glasgow Coma Score (GCS) \< 7 * Intracerebral hematoma volume \> 30 cm3 as assessed by computed tomography (CT) scan * For subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm, or acute subdural hematomas (based on neurosurgeon review) * For subarachnoid hemorrhage: any evidence of hydrocephalus, or Hunt and Hess Scale \> 2, or concomitant subdural he…