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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

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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

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Hypertriglyceridaemia; Lipodystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms BROADEN
  • Sponsors Akcea Therapeutics; Ionis Pharmaceuticals

    • Most Recent Events

    • 28 Jan 2023 This trial was completed in Italy according to European Clinical Trials Database
    • 01 Dec 2022 According to a PTC Therapeutics media release, the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), has approved Waylivra (volanesorsen) as the first treatment for familial partial lipodystrophy (FPL) in Brazil.
    • 21 Sep 2021 Status changed from active, no longer recruiting to discontinued.
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