Prothrombin Complex Concentrate for Anticoagulant Reversal

February 10, 2011 updated by: CSL Behring

Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation

Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

Study Overview

Status

Completed

Conditions

Acquired Coagulation Factor Deficiency

Intervention / Treatment

Drug: Prothrombin Complex Concentrate

Study Type

Interventional

Enrollment

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Feldkirch, Austria, 6800
    - Clinical Trials Registration Coordinator
  - Wien, Austria, 1090
    - Clinical Trials Registration Coordinator
Germany
- - Halle/Saale, Germany, 06112
    - Clinical Trials Registration Coordinator
  - Hannover, Germany, 30623
    - Clinical Trials Registration Coordinator
  - Leipzig, Germany, 04129
    - Clinical Trials Registration Coordinator
  - Marburg, Germany, 35002
    - For information on sites in Europe, please contact our clinical research team in
  - München, Germany, 81377
    - Clinical Trials Registration Coordinator
Hungary
- - Györ, Hungary, 9023
    - Clinical Trials Registration Coordinator
  - Veszprém, Hungary, 8220
    - Clinical Trials Registration Coordinator
Israel
- - Haifa, Israel, 31096
    - Clinical Trials Registration Coordinator
Lithuania
- - Kaunas, Lithuania, 500009
    - Clinical Trials Registration Coordinator
  - Vilnius, Lithuania, 08661
    - Clinical Trials Registration Coordinator
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Clinical Trials Registration Coordinator
Poland
- - Warsaw, Poland, 02-097
    - Clinical Trials Registration Coordinator
Switzerland
- - Zuerich, Switzerland, 8091
    - Clinical Trials Registration Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
INR > 2 at baseline

Key Exclusion Criteria:

Acute thromboembolic event
Treatment with any other investigational drug in the last 30 days before study entry
Less than 2 weeks of stable oral anticoagulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rapid reversal of anticoagulatory effect

Secondary Outcome Measures

Outcome Measure
Clinical efficacy assessment (hemostatic effect)
Increase of coagulation factors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

Principal Investigator: Ingrid Pabinger-Fasching, Prof., Universitätsklinik für Innere Medizin I der Stadt Wien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BE1116_3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.