Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

  • STATUS
    Recruiting
  • participants needed
    274
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 28 May 2022
heparin
anticoagulants
vitamin k antagonist
anticoagulant therapy
probe
vitamin k
venous thromboembolism
thromboembolism
edoxaban
heparin therapy

Summary

This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

Description

The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent VTE, death as result of VTE, and no change or extension of thrombotic burden) during the first 3-month treatment period.

Details
Condition Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
Treatment Standard of Care, Edoxaban
Clinical Study IdentifierNCT02798471
SponsorDaiichi Sankyo, Inc.
Last Modified on28 May 2022

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