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: 24 Jul 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

    • 14 Jun 2017 Planned End Date changed from 1 Apr 2018 to 1 Dec 2018.
    • 10 Jun 2017 Biomarkers information updated
    • 08 May 2017 According to a Faron Pharmaceuticals media release, on 4 May 2017, the Independent Data Monitoring Committee (IDMC) has recommended to Faron that the trial should continue as planned with no changes, consistent with the recommendation received from IDMC as a result of three previous meetings.
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