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Sponsored by: |
CSL Behring |
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Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00803101 |
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 because of emergency surgery or urgent invasive intervention.
Condition | Intervention | Phase |
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Reversal of Coagulopathy |
Biological: Beriplex® P/N Biological: Fresh frozen plasma |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, 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 Requiring Emergency Surgery or Invasive Intervention |
Estimated Enrollment: | 155 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (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: Clinical Trials Registration Coordinator | +49 6421 393548 | clinicaltrials@cslbehring.com |
United States, Delaware | |
Contact CSL Behring for facility details | Recruiting |
Newark, Delaware, United States, 19718 | |
United States, Maryland | |
Contact CSL Behring for facility details | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Armenia | |
Contact CSL Behring for facility details | Not yet recruiting |
Yerevan, Armenia, 0087 | |
Russian Federation | |
Contact CSL Behring for facility details | Recruiting |
Kemerovo, Russian Federation, 650002 | |
Contact: Clinical Trials Registration Coordinator clinicaltrials@cslbehring.com | |
Contact CSL Behring for facility details | Recruiting |
Arkhangelsk, Russian Federation, 163061 | |
Contact CSL Behring for facility details | Not yet recruiting |
Barnaul, Russian Federation, 656024 | |
Contact CSL Behring for facility details | Not yet recruiting |
Nizhny Novgorod, Russian Federation, 603001 | |
Contact CSL Behring for facility details | Not yet recruiting |
Moscow, Russian Federation, 105203 | |
Ukraine | |
Contact CSL Behring for facility details | Not yet recruiting |
Kharkov, Ukraine, 61018 |
Responsible Party: | CSL Behring ( Global Head Clinical Research & Development ) |
Study ID Numbers: | 1474, BE1116_3003, EUDRACT-Number 2007-007862-39 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803101 |
Health Authority: | United States: Food and Drug Administration; Russia: Federal Service for Surveillance in Healthcare and Social Development; Armenia: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health |
Anticoagulant reversal Prothrombin Complex Concentrate Coagulopathy Coumarin derivatives |
Emergency surgery Invasive procedures Vitamin K Reversal of coagulopathy induced by coumarin derivatives |
Thrombin Hemorrhagic Disorders Hematologic Diseases Blood Coagulation Disorders |
Vitamin K Vascular Diseases Emergencies Hemostatic Disorders |
Disease Attributes Pathologic Processes Cardiovascular Diseases |