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

PHASE3CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

March 31, 2016

Conditions
Acute Major BleedingReversal of Coagulopathy
Interventions
BIOLOGICAL

BE1116 (Prothrombin Complex Concentrate)

Trial Locations (11)

113-8603

Nippon Medical School Hospital, Sendagi

810-8563

Kyushu Medical Center, Chūōku

270-1694

Nippon Medical School Chiba Hokusoh Hospital, Kamagari

710-0052

Kurashiki Central Hospital, Miwa

540-0006

Osaka National Hospital, Chuo-ku

577-0818

Kinki University, Higashiosaka

565-0873

National Cerebral and Cardiovascular Center, Suita

980-8574

Tohoku University Hospital, Aoba-ku

162-0052

National Center for Global Health and Medicine, Toyama

565-0871

Osaka University Hospital, Yamadaoka

104-8560

St. Luke's International Hospital, Chūō

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY