Prothrombin Complex Concentrate for Anticoagulant Reversal

This study has been completed.
Sponsor:
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168077
First received: September 12, 2005
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Acquired Coagulation Factor Deficiency
Drug: Prothrombin Complex Concentrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Rapid reversal of anticoagulatory effect

Secondary Outcome Measures:
  • Clinical efficacy assessment (hemostatic effect)
  • Increase of coagulation factors

Estimated Enrollment: 40
Study Start Date: September 2005
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168077

Locations
Austria
Clinical Trials Registration Coordinator
Feldkirch, Austria, 6800
Clinical Trials Registration Coordinator
Wien, Austria, 1090
Germany
Clinical Trials Registration Coordinator
Halle/Saale, Germany, 06112
Clinical Trials Registration Coordinator
Hannover, Germany, 30623
Clinical Trials Registration Coordinator
Leipzig, Germany, 04129
For information on sites in Europe, please contact our clinical research team in
Marburg, Germany, 35002
Clinical Trials Registration Coordinator
München, Germany, 81377
Hungary
Clinical Trials Registration Coordinator
Györ, Hungary, 9023
Clinical Trials Registration Coordinator
Veszprém, Hungary, 8220
Israel
Clinical Trials Registration Coordinator
Haifa, Israel, 31096
Lithuania
Clinical Trials Registration Coordinator
Kaunas, Lithuania, 500009
Clinical Trials Registration Coordinator
Vilnius, Lithuania, 08661
Netherlands
Clinical Trials Registration Coordinator
Amsterdam, Netherlands, 1105 AZ
Poland
Clinical Trials Registration Coordinator
Warsaw, Poland, 02-097
Switzerland
Clinical Trials Registration Coordinator
Zuerich, Switzerland, 8091
Sponsors and Collaborators
CSL Behring
Investigators
Principal Investigator: Ingrid Pabinger-Fasching, Prof. Universitätsklinik für Innere Medizin I der Stadt Wien
  More Information

Additional Information:
Publications:
Responsible Party: Global Head Clinical Research & Development, CSL Behring
ClinicalTrials.gov Identifier: NCT00168077     History of Changes
Other Study ID Numbers: BE1116_3001
Study First Received: September 12, 2005
Last Updated: February 10, 2011
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by CSL Behring:
Prothrombin Complex Concentrate
Anticoagulant reversal

Additional relevant MeSH terms:
Anticoagulants
Thrombin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on July 26, 2014