A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Intravenous MR11A8 in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome

Trial Profile

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Intravenous MR11A8 in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2017

At a glance

  • Drugs Interferon beta-1a (Primary)
  • Indications Adult respiratory distress syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Maruishi Pharmaceutical
  • Most Recent Events

    • 06 Sep 2017 According to a Faron Pharmaceuticals media release, company anticipates completion of patient recruitment during H1 2018.
    • 04 Sep 2017 According to a Faron Pharmaceuticals media release, the FDA has proposed that Faron can proceed directly to Biologics License Application (BLA) submission pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) with the Traumakine for the treatment of Acute Respiratory Distress Syndrome (ARDS).
    • 29 Mar 2017 Status changed from not yet recruiting to recruiting, according to a Faron Pharmaceuticals media release.
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