Acute Major Bleeding

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

NCT02281201 | PHASE 3 | INTERVENTIONAL

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.

11 Sites

11 Participants

Recruiting

20 Years to 55 Years

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SUBMIT

Nippon Medical School Hospital

Sendagi,Bunkyo,Japan,113-8603

Kyushu Medical Center

Chuo-ku,Fukuoka,Japan,810-8563

Nippon Medical School Chiba Hokusoh Hospital

Kamagari,Inzai,Japan,270-1694

Kurashiki Central Hospital

Miwa,Kurashiki,Japan,710-0052

Osaka National Hospital

Chuo-ku,Osaka,Japan,540-0006

Kinki University

Higashiosaka,Osaka,Japan,577-0818

National Cerebral and Cardiovascular Center

Suita,Osaka,Japan,565-0873

Tohoku University Hospital

Aoba-ku,Sendai,Japan,980-8574

National Center for Global Health and Medicine

Toyama,Shinjuku,Japan,162-0052

Osaka University Hospital

Yamadaoka,Suita,Japan,565-0871

St. Luke's International Hospital

Chuo,Tokyo,Japan,104-8560

Study Eligibility Criteria

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

Additional Studies

Additional studies can be found at ClinicalTrials.gov