An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure
An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who require immediate correction of international normalized ratio (INR) due to a major bleed or emergency surgery.
Inclusion Criteria:
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):
Kamagari, Inzai 270-1694, Japan
Chuo-ku, Osaka 540-0006, Japan
Aoba-ku, Sendai 980-8574, Japan
Yamadaoka, Suita 565-0871, Japan