At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 94 enrolled
Drug / intervention
Givosiran +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Givosiran and Placebo for Acute Hepatic Porphyria and 6 related conditions. Completed, enrolled 94 participants across 36 sites in 18 countries.
Detailed Summary
The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria, Hereditary Coproporphyria (HCP), Variegate Porphyria (VP), ALA Dehydratase Deficient Porphyria (ADP)
CountriesAustralia, Bulgaria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionJan 2019
Study CompletionMay 2021
TodayJul 2026
First PostedNov 9, 2017
Enrollment StartNov 16, 2017
Primary CompletionJan 31, 2019
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.6 years ago
Interventions
Givosirandrug
Givosiran by SC
Placebodrug
Matching placebo (normal saline \[0.9% NaCl\]) by SC