A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents

Trial Profile

A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2017

At a glance

  • Drugs OMS 721 (Primary)
  • Indications Haemolytic uraemic syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Omeros Corporation
  • Most Recent Events

    • 08 Sep 2016 Status changed from not yet recruiting to recruiting, as reported by an Omeros Corporation media release.
    • 28 Jul 2016 According to an Omeros Corporation media release, based on the advice from the European Medicines Agency (EMA) the company plans to run the same, single Phase 3 clinical program to support OMS721 marketing approval applications in both the U.S. and in the European Union for the treatment of atypical hemolytic uremic syndrome (aHUS).
    • 08 Mar 2016 Patient enrollment is expected to begin later this year, according to an Omeros Corporation media release.
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