CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 176 enrolled
Drug / intervention
Beriplex® P/N (Kcentra) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00803101
NCT00803101Phase 3Completed
CompareCT.gov

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 Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

CSL Behring·interventional·Posted Dec 5, 2008·Updated Apr 6, 2015

In Brief

A Phase 3 clinical trial evaluating Beriplex® P/N (Kcentra) and Fresh frozen plasma for Reversal of Coagulopathy. Completed, enrolled 176 participants across 30 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 vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsReversal of Coagulopathy
CountriesBelarus, Bulgaria, Lebanon, Romania, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartFeb 1, 2009
Primary CompletionNov 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.6 years ago

Interventions

Beriplex® P/N (Kcentra)biological

Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.

Fresh frozen plasmabiological

Intravenous infusion, dosage depending on baseline INR and body weight