A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 17 Nov 2017

At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Lipodystrophy
  • Focus Therapeutic Use
  • Acronyms BROADEN
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 27 Jul 2017 According to a company media release, Akcea plans to file for marketing authorization for volanesorsen to treat familial partial lipodystrophy (FPL) in 2019 if the data from the BROADEN study are positive.
    • 25 Apr 2017 Planned primary completion date changed from 1 Sep 2017 to 30 Sep 2017.
    • 19 Dec 2016 According to an Akcea Therapeutics media release, company plans to have data from this study in 2019.
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