A Phase III Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome

Trial Profile

A Phase III Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome

Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

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

    • 06 Sep 2017 According to a Faron Pharmaceuticals media release, patient recruitment is anticipated to be completed in Q4 2017.
    • 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).
    • 14 Jun 2017 Planned End Date changed from 1 Apr 2018 to 1 Dec 2018.
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