Clinical trial
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in…
NCT03338816 · Alnylam Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT03338816 |
|---|---|
| Title | ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP) |
| Official title | 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 |
| Lead sponsor | Alnylam Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Acute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria, Hereditary Coproporphyria (HCP), Variegate Porphyria (VP), ALA Dehydratase Deficient Porphyria (ADP) |
| Intervention type | Drug |
| Interventions | Givosiran, Placebo |
| Enrollment | 94 |
| Start date | Nov 16, 2017 |
| Primary completion | Jan 31, 2019 |
| Completion | May 31, 2021 |
| First posted | Nov 9, 2017 |
| Last update posted | Apr 22, 2024 |
| Countries | Australia, Bulgaria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, Poland and 6 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: