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NCT03338816 · ClinicalTrials.gov registry record · Phase 3
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
A Phase 3 study of Acute Hepatic Porphyria and Acute Intermittent Porphyria, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT03338816 is a Phase 3 study of Acute Hepatic Porphyria and Acute Intermittent Porphyria that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 94 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT03338816, a Phase 3 study of Acute Hepatic Porphyria and Acute Intermittent Porphyria, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Givosiran
Study Locations (20)
Other
- Clinical Trial Site - Auchenflower
- Clinical Trial Site - Camperdown
- Clinical Trial Site - Sofia
- Clinical Trial Site - Edmonton
- Clinical Trial Site - Odense
- Clinical Trial Site - Helsinki
- Clinical Trial Site - Paris
- Clinical Trial Site - Chemnitz
- Clinical Trial Site - Munich
Arkansas
- Clinical Trial Site - Little Rock
California
- Clinical Trial Site - San Francisco
Massachusetts
- Clinical Trial Site - Boston
Michigan
- Clinical Trial Site - Ann Arbor
New York
- Clinical Trial Site - New York
North Carolina
- Clinical Trial Site - Winston-Salem
Pennsylvania
- Clinical Trial Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03338816
The ClinicalTrials.gov registry entry for NCT03338816 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alnylam Pharmaceuticals, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Acute Hepatic Porphyria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03338816 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT03338816 about?
NCT03338816 is a clinical study titled "ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)". 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).
What is the current status of trial NCT03338816?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2017-11-16. Estimated completion is 2021-05-31.
What conditions does trial NCT03338816 study?
This clinical trial studies the following conditions: Acute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria, Hereditary Coproporphyria (HCP).
What interventions are being tested in trial NCT03338816?
The interventions under investigation include: Placebo (DRUG), Givosiran (DRUG).
Who is sponsoring clinical trial NCT03338816?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03338816 being conducted?
This trial has 20 study locations across Arkansas, California, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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