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Sponsored by: |
CSL Behring |
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Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00708435 |
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 |
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Blood Coagulation Disorders Acute Major Bleeding |
Biological: Beriplex® P/N Biological: Fresh frozen plasma |
Phase III |
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 |
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 |
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Beriplex® P/N: Experimental |
Biological: Beriplex® P/N
Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
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Fresh frozen plasma: Active Comparator |
Biological: Fresh frozen plasma
Intravenous Infusion, dosage depending on baseline INR and body weight
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Astrid Schneider | +49 6421 393548 | |
Contact: Sigurd Knaub | +49 6421 393224 |
United States, Texas | |
Contact CSL Behring for facility details | Recruiting |
Dallas, Texas, United States |
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 |
Anticoagulant reversal Prothrombin Complex Concentrate |
Coagulopathy induced by coumarin derivatives |
Thrombin Hemorrhagic Disorders Hematologic Diseases Blood Coagulation Disorders |
Vascular Diseases Hemorrhage Hemostatic Disorders |
Pathologic Processes Cardiovascular Diseases |