Status:
COMPLETED
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
Lead Sponsor:
CSL Behring
Conditions:
Acute Major Bleeding
Reversal of Coagulopathy
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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 antagon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02281201
Start Date
October 1 2014
End Date
March 1 2016
Last Update
May 4 2016
Active Locations (11)
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1
Nippon Medical School Hospital
Sendagi, Bunkyo, Japan, 113-8603
2
Kyushu Medical Center
Chūōku, Fukuoka, Japan, 810-8563
3
Nippon Medical School Chiba Hokusoh Hospital
Kamagari, Inzai, Japan, 270-1694
4
Kurashiki Central Hospital
Miwa, Kurashiki, Japan, 710-0052