Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
400
Trial Sponsor
Clinical Trial Start Date
2005
0Study Completion Date
2006
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 30
Official Name
Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation0
Last Updated
February 11, 2011
0Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary
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.
Timeline
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Further Resources
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