ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias

Trial Profile

ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Apr 2018

At a glance

  • Drugs Givosiran (Primary)
  • Indications Acute intermittent porphyria
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVISION
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 14 Apr 2018 According to an Alnylam Pharmaceuticals media release, the company expects to enroll the thirtieth patient into this trial in the coming weeks.
    • 08 Feb 2018 According to an Alnylam Pharmaceuticals media release, sample size will adjust from approximately 75 patients to up to approximately 94 patients.
    • 08 Feb 2018 According to an Alnylam Pharmaceuticals media release, it expects interim analysis results in mid-2018 and, pending FDA review of the program at the time of interim analysis and assuming positive results, it expects to submit an NDA at or around year-end 2018.
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