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Clinical Trial Summary

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04867837
Study type Interventional
Source Octapharma
Contact Sigurd Knaub, PhD
Phone +41554512141
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date July 2021
Completion date February 2024

See also
  Status Clinical Trial Phase
Completed NCT02281201 - Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects Phase 3
Completed NCT00708435 - Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy Phase 3