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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Thrombomodulin alfa (Primary)
  • Indications Blood coagulation disorders; Sepsis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SCARLET
  • Sponsors Asahi Kasei Pharma America Corp

    • Most Recent Events

    • 14 Jun 2019 Status changed from active, no longer recruiting to completed.
    • 19 May 2019 Results evaluating the effect of human recombinant thrombomodulin vs placebo among patients with sepsis-associated coagulopathy published in the JAMA: the Journal of the American Medical Association
    • 02 Aug 2018 Primary endpoint has not been met. (Primary Efficacy Outcome Measure), as per results published in an Asahi Kasei Pharma America media release.

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