Trials / Completed
CompletedNCT03338816
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
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
- Phase 3
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Acute Hepatic Porphyria
- Acute Intermittent Porphyria
- Porphyria, Acute Intermittent
- Acute Porphyria
- Hereditary Coproporphyria (HCP)
- Variegate Porphyria (VP)
- ALA Dehydratase Deficient Porphyria (ADP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Givosiran | Givosiran by SC |
| DRUG | Placebo | Matching placebo (normal saline \[0.9% NaCl\]) by SC |
Timeline
- Start date
- 2017-11-16
- Primary completion
- 2019-01-31
- Completion
- 2021-05-31
- First posted
- 2017-11-09
- Last updated
- 2024-04-22
- Results posted
- 2020-02-11
Locations
36 sites across 18 countries: United States, Australia, Bulgaria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03338816. Inclusion in this directory is not an endorsement.