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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2025

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At a glance

  • Drugs Givosiran (Primary)
  • Indications Acute intermittent porphyria; Aminolevulinate dehydrase deficiency porphyria; Hepatic-porphyria; Hereditary coproporphyria; Variegate-porphyria
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVISION
  • Sponsors Alnylam Pharmaceuticals

Most Recent Events

  • 01 Jun 2024 Results assessing the long-term efficacy and safety of givosiran in Taiwanese participants published in the Journal of the Formosan Medical Association
  • 19 Jul 2023 Results from the 36-month final analysis of ENVISION, published in the Journal of Hepatology
  • 24 Jun 2023 Results assessing long-term treatment outcomes, qualitative interviews were conducted with study participants from Phase 1/2(NCT02949830) and Phase 3 (ENVISION; NCT03338816) studies, presented at the European Association for the Study of the Liver Congress 2023.

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