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Clinical trial

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.

NCT02740335 is registered in ClinicalTrials.gov with Octapharma as lead sponsor.

NCT NCT02740335
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Octapharma
Phase
Phase 3
Overall status
Completed
Start date
June 8, 2017
Completion date
February 23, 2022
Enrollment
208 (actual)
Sites
86

Conditions

As the registry lists them; a condition with its own page is linked.

significant bleeding risk