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

NCT ID: NCT02281201

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

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 antagonists in Japanese subjects who require immediate correction of international normalized ratio (INR) due to a major bleed or emergency surgery.

Conditions

Acute Major Bleeding; Reversal of Coagulopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BE1116

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

Group Type: EXPERIMENTAL

BE1116 (Prothrombin Complex Concentrate)

Intervention Type: BIOLOGICAL

Interventions

BE1116 (Prothrombin Complex Concentrate)

Intervention Type: BIOLOGICAL

Other Intervention Names

Beriplex® P/N; KcentraTM; Confidex®

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Program Director, Acquired Bleeding

Role: STUDY_DIRECTOR

CSL Behring

Locations

Nippon Medical School Hospital

Sendagi, Bunkyo, Japan

Kyushu Medical Center

Chūōku, Fukuoka, Japan

Nippon Medical School Chiba Hokusoh Hospital

Kamagari, Inzai, Japan

Kurashiki Central Hospital

Miwa, Kurashiki, Japan

Osaka National Hospital

Chuo-ku, Osaka, Japan

Kinki University

Higashiosaka, Osaka, Japan

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Tohoku University Hospital

Aoba-ku, Sendai, Japan

National Center for Global Health and Medicine

Toyama, Shinjuku, Japan

Osaka University Hospital

Yamadaoka, Suita, Japan

St. Luke's International Hospital

Chūō, Tokyo, Japan

Countries

Japan

Other Identifiers

BE1116_3004

Identifier Type: -

Identifier Source: org_study_id