Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation - N/A

• Conditions: Acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).; MedDRA version: 7.1Level: LLTClassification code 10000534

• Registration Number: EUCTR2005-000382-19-DE
• Lead Sponsor: ZLB Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Male and female subjects >= 18 years

Subjects
with anticoagulation therapy (coumarin or derivatives) in whom either an emergency surgical or an urgent invasive diagnostic intervention is indicated
OR
with anticoagulation therapy (coumarin or derivatives) and acute bleedings in whom normalization of INR is indicated

INR > 2

Informed consent has been obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Treatment with any other investigational medicinal product in the last 30 days before study entry
Administration of whole blood, plasma or plasma fractions within the previous 2 weeks before study entry
Presence or history of hypersensitivity to the study medication
History of heparin-induced thrombocytopenia type II
Known inhibitors to coagulation factors II, VII, IX or X
Known hereditary protein C deficiency
Preexisting progressive fatal disease/life expectancy of less than 3 months
Less than two weeks of stable oral anticoagulation in the intended therapeutic range in patients with a recent history of DVT or pulmonary embolism
Acute angina pectoris, acute thrombosis, acute myocardial infarction, acute disseminated intravascular coagulation, acute sepsis, severe ischemic vascular disorder
Pregnant women, women currently breast-feeding, or with the intention of breast-feeding
Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study (for details see 11.3 Informed consent of subject)
Evidence of an uncooperative attitude and/or drug addiction (including alcohol abuse)
Prior inclusion in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the capability of Beriplex® P/N to effectively reverse the oral anticoagulation effect by decreasing the INR values;Secondary Objective: To demonstrate the capability of Beriplex® P/N to adequately increase the plasma level of coagulation factors II, VII, IX, X and protein C<br><br>To demonstrate the cessation of spontaneously and traumatically induced bleedings or avoidance of excessive hemorrhages during and after emergency surgical interventions<br><br>To determine the safety and tolerability of Beriplex® P/N;Primary end point(s): The primary efficacy endpoint is the rapid decrease of the INR (i.e. INR = 1.3 within 30 minutes after end of Beriplex® P/N infusion).