NCT00168077

Prothrombin Complex Concentrate for Anticoagulant Reversal

Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Coagulation Factor Deficiency

Interventions

Type	Name	Description
DRUG	Prothrombin Complex Concentrate

Timeline

• Start date: 2005-09-01
• Completion: 2006-11-01
• First posted: 2005-09-14
• Last updated: 2011-02-11

Locations

15 sites across 8 countries: Austria, Germany, Hungary, Israel, Lithuania, Netherlands, Poland, Switzerland