A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
Phase of Trial: Phase III
Latest Information Update: 09 Mar 2018
At a glance
- Drugs Prothrombin complex concentrate (Primary)
- Indications Surgical blood loss
- Focus Registrational; Therapeutic Use
- Sponsors Octapharma
- 09 May 2017 Status changed from not yet recruiting to recruiting.
- 22 Nov 2016 Planned initiation date changed from 1 Dec 2016 to 1 Mar 2017.
- 18 Apr 2016 New trial record