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A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ciraparantag for Reversal of Anticoagulation in Healthy Adults

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Trial Profile

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ciraparantag for Reversal of Anticoagulation in Healthy Adults

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Jul 2023

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At a glance

  • Drugs Apixaban (Primary) ; Ciraparantag (Primary) ; Edoxaban (Primary) ; Rivaroxaban (Primary)
  • Indications Haemorrhage
  • Focus Therapeutic Use
  • Sponsors Perosphere

    • Most Recent Events

    • 18 Jul 2023 Planned End Date changed from 1 Dec 2022 to 1 Dec 2023.
    • 18 Jul 2023 Planned primary completion date changed from 1 Dec 2022 to 1 Dec 2023.
    • 18 Feb 2022 Arms amended from 2 to 3. Cohort 1 with anticoagulant drug Edoxaban added newly. Secondary endpoints Cmax, C24, tmax, AUC(0-last), AUC(0-inf), AUC(0-12), apparent terminal rate constant, half life, systemic clearance after IV dose, systemic clearance after oral dose, Vz after IV dose, MR Cmax, MR AUC(0-last) and MR AUC(0-inf) are removed.
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