At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Beriplex® P/N (Kcentra) and Fresh frozen plasma for Blood Coagulation Disorders and Acute Major Bleeding. Completed, enrolled 216 participants across 69 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) 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.
Study Details
Timeline
Interventions
Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
Intravenous Infusion, dosage depending on baseline INR and body weight