ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria, Hereditary Coproporphyria (HCP), Variegate Porphyria (VP), ALA Dehydratase Deficient Porphyria (ADP)
In brief
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).
Key facts
- Study ID
- NCT03338816
- Run by
- Alnylam Pharmaceuticals
- People needed
- 94
- Starts
- 2017-11-16
- Expected to finish
- 2021-05-31
- Last updated by the study team
- 2024-04-22
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 12 years of age
- Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Corproporhyria, Variegate Porphyria, aminolevulinic acid (ALA) dehydratase deficient porphyria)
- Elevated urinary or plasma porphobilinogen (PBG) or ALA values within the past year,
- Have active disease, with at least 2 documented porphyria attacks within the last 6 months
- Willing to discontinue or not initiate the use of prophylactic hemin throughout the study.
- Women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception
You may not qualify if…
- Clinically significant abnormal laboratory results
- Anticipated liver transplantation
- History of multiple drug allergies or intolerance to subcutaneous injections
- Active HIV, hepatitis C virus, or hepatitis B virus infection(s)
- History of recurrent pancreatitis
Where it is running
- Clinical Trial Site — Little Rock, Arkansas, United States
- Clinical Trial Site — San Francisco, California, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Ann Arbor, Michigan, United States
- Clinical Trial Site — New York, New York, United States
- Clinical Trial Site — Winston-Salem, North Carolina, United States
- Clinical Trial Site — Philadelphia, Pennsylvania, United States
- Clinical Trial Site — Galveston, Texas, United States
- Clinical Trial Site — Salt Lake City, Utah, United States
- Clinical Trial Site — Seattle, Washington, United States
- Clinical Trial Site — Parkville, Victoria, Australia
- Clinical Trial Site — Auchenflower, Australia
- Clinical Trial Site — Camperdown, Australia
- Clinical Trial Site — Sofia, Bulgaria
- Clinical Trial Site — Edmonton, Canada
- Clinical Trial Site — Odense, Denmark
- Clinical Trial Site — Helsinki, Finland
- Clinical Trial Site — Paris, France
- Clinical Trial Site — Chemnitz, Germany
- Clinical Trial Site — Munich, Germany
- Clinical Trial Site — Modena, Italy
- Clinical Trial Site — Hamamatsu, Japan
- Clinical Trial Site — Iizuka, Japan
- Clinical Trial Site — Tokyo, Japan
- Clinical Trial Site — Mexico City, Mexico
Full record on ClinicalTrials.gov
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