Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Major Bleeding Reversal of Coagulopathy

Outcome Measures

Primary Outcomes (1)

Percentage of Subjects With a Rapid Reversal of VKA Effect
A rapid reversal of (Vitamin K antagonist) VKA effect is a reduction of the INR to ≤ 1.3 at 30 minutes after the end of infusion.
At baseline and at 30 minutes after the end of infusion

Secondary Outcomes (15)

Percentage of Subjects Achieving Hemostatic Efficacy During Surgery
From the start of surgery/procedure until the end of surgery/procedure
Percentage of Subjects Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed
Baseline CT scan, baseline haematology or the end of infusion, until 24 hours after the end of infusion
Increase in Plasma Levels of Factor (F)II, FVII, FIX, and FX, and Protein C and Protein S
Before infusion and up to 3 h after the start of infusion
Percentage of Subjects With INR Correction
From the start of infusion until INR correction, up to 24 hours after the end of infusion
Percentage of Subjects With INR Correction at Various Times After the End of Infusion
From the end of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the end of infusion
+10 more secondary outcomes

Study Arms (1)

BE1116

EXPERIMENTAL

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

Biological: BE1116 (Prothrombin Complex Concentrate)

Interventions

BE1116 (Prothrombin Complex Concentrate)Biological

Also known as: Beriplex® P/N, KcentraTM, Confidex®

BE1116

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and female Japanese subjects greater than or equal to 20 years
Subjects currently on vitamin K antagonist (VKA) therapy

Sponsors & Collaborators

CSL Behring
Industrylead

Study Sites (11)

Nippon Medical School Hospital

Sendagi, Bunkyo, 113-8603, Japan

Kyushu Medical Center

Chūōku, Fukuoka, 810-8563, Japan

Nippon Medical School Chiba Hokusoh Hospital

Kamagari, Inzai, 270-1694, Japan

Kurashiki Central Hospital

Miwa, Kurashiki, 710-0052, Japan

Osaka National Hospital

Chuo-ku, Osaka, 540-0006, Japan

Kinki University

Higashiosaka, Osaka, 577-0818, Japan

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-0873, Japan

MeSH Terms

Interventions

Factor IX

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

Program Director, Acquired Bleeding
CSL Behring
STUDY DIRECTOR

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 3, 2014

Study Start

October 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (1)

BE1116

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (1)

BE1116

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations