Efficacy and Safety Study of BERIPLEX® P/N Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00708435

Purpose

The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.

Condition	Intervention	Phase
Blood Coagulation Disorders Acute Major Bleeding	Biological: Beriplex® P/N Biological: Fresh frozen plasma	Phase III

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders Blood Thinners

Drug Information available for: Factor IX BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Coumarin Derivatives in Subjects With Acute Major Bleeding

Further study details as provided by CSL Behring:

Primary Outcome Measures:

hemostatic efficacy with respect to the adequacy of stopping an ongoing major bleed [ Time Frame: 24 h from start of infusion ] [ Designated as safety issue: No ]
Proportion of subjects who have a rapid decrease of the INR [ Time Frame: 30 minutes after end of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response and in vivo recovery (IVR) of coagulation factors II, VII, IX and X, protein c and protein S [ Time Frame: 3 h after administration ] [ Designated as safety issue: No ]
45-Day all-cause mortality [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	176
Study Start Date:	June 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Beriplex® P/N: Experimental	Biological: Beriplex® P/N Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
Fresh frozen plasma: Active Comparator	Biological: Fresh frozen plasma Intravenous Infusion, dosage depending on baseline INR and body weight

Eligibility

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

Criteria

Inclusion Criteria:

Male and female subjects >= 18 years
Subjects who have received anticoagulation therapy(warfarin, acenocoumarol or phenprocoumon) and who have acute major bleeding
INR >= 2 within 3 hours before start of study treatment
Informed consent has been obtained

Exclusion Criteria:

Expected survival of less than 3 days, or expected surgery in less than 1 day
Acute polytrauma (e.g. major motor vehicle accidents, penetrating injury or fall of > 20 feet (> 6 meters))
For patients with ICH: Glasgow coma score < 9; Hematoma volume > 30cc as assessed by ABC/2, ABC/3 methods or best estimate. For subdural hematomas: maximum thickness < 10 mm, midline shift < 5 mm.For subarachnoid hemorrhage: any evidence of hydrocephalus. Infratentorial ICH location. Ambulatory without assistance prior to ICH
Acute thrombosis, acute myocardial infarction, acute disseminated intravascular coagulation, acute angina pectoris, acute sepsis, or severe ischemic vascular disorder
A previous thromboembolic event within 30 days prior to inclusion into the study
Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study
Large blood vessel rupture
Pre-existing progressive fatal disease with a life expectancy of less than 2 months
Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C deficiency; or heparin-induced, type II thrombocytopenia
Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study
Presence or history of hypersensitivity to components of the study medication
Pregnant or breast-feeding women
Prior inclusion in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708435

Contacts

Contact: Astrid Schneider	+49 6421 393548
Contact: Sigurd Knaub	+49 6421 393224

Locations

United States, Texas
Contact CSL Behring for facility details	Recruiting
Dallas, Texas, United States

Sponsors and Collaborators

CSL Behring

More Information

Responsible Party:	CSL Behring ( Dr. Sigurd Knaub, Program Director )
Study ID Numbers:	1462, EUDRACT-Number 2007-007861-19
Study First Received:	July 1, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00708435
Health Authority:	United States: Food and Drug Administration

Keywords provided by CSL Behring:

Anticoagulant reversal
Prothrombin
Complex
Concentrate

Coagulopathy
induced by
coumarin
derivatives

Study placed in the following topic categories:

Thrombin
Hemorrhagic Disorders
Hematologic Diseases
Blood Coagulation Disorders

Vascular Diseases
Hemorrhage
Hemostatic Disorders

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009