A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy

Trial Profile

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy

Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Aug 2017

At a glance

  • Drugs Inotersen (Primary)
  • Indications Amyloid polyneuropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms NEURO-TTR
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 11 Aug 2017 Status changed from active, no longer recruiting to completed, according to an Ionis Pharmaceuticals media release.
    • 08 Aug 2017 Ionis Pharmaceuticals and GSK are preparing to file for regulatory approval for inotersen in the U.S. and EU by the end of 2017, based on the data from this trial.
    • 10 Jul 2017 According to an Ionis Pharmaceuticals media release, company is continuing to review the full data package from this study and prepare the regulatory marketing applications for submission in 2017.
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