drugset
drugset / Trial / NCT04867837

Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

NCT04867837 ↗

Phase 3 Terminated 100 enrolled Octapharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-09-01
Primary completion
2026-01-13
Completion
2026-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Octaplex Protein / enzyme biologic — Intravenous

Indications

No indication recorded.