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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.

Trial Information
11 Sites
11 Participants
Recruiting
20 Years to 65 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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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

Additional Studies

Additional studies can be found at ClinicalTrials.gov