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

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Reversal of Coagulopathy; Acute Major Bleeding

Treatments: Biological: BE1116 (Prothrombin Complex Concentrate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02281201

BE1116_3004

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 hematoma
  • Infratentorial ICH location
  • Epidural hematomas
  • Intraventricular rupture of hemorrhage
  • Requires surgical intervention

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

BE1116

Experimental group

Description:

Single intravenous (I.V.) infusion, dosage depending on baseline INR and body weight

Treatment:

Biological: BE1116 (Prothrombin Complex Concentrate)