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
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
- 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.