What this study is
The purpose of this study is to obtain safety, efficacy, and pharmacodynamic data on the use of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy who continued on extended use of vutrisiran, or switched from patisiran.
What's being tested
- Vutrisiran
Intervention · DRUG
Vutrisiran administered SC q3M
Study details
- Official title
- An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
- Sponsor
- Alnylam Pharmaceuticals
- Conditions
- Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
- Enrolling
- 700 people
- Starts
- 2024-12-03
- Est. completion
- 2028-03-31
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003
You can't join if
- Has permanently discontinued study drug administration while participating in the parent studies, ALN-TTR02-011, ALN-TTR02-014, or ALN-TTRSC02-003
- Future or current participation in another investigational device or drug study, scheduled to occur during this study
- Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (87)
87 openClinical Trial Site
Phoenix, Arizona, United States
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Beverly Hills, California, United States
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La Jolla, California, United States
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Stanford, California, United States
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Washington D.C., District of Columbia, United States
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Chicago, Illinois, United States
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Glenview, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
63 sites outside the US
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Córdoba, Argentina
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Rosario, Argentina
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Rosario, Argentina
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Rosario, Argentina
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Vienna, Austria
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Vienna, Austria
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Aalst, Belgium
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Anderlecht, Belgium
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Dendermonde, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Ribeirão Preto, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Aarhus N, Denmark
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København Ø, Denmark
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Odense C, Denmark
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Créteil, France
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Marseille, France
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Paris, France
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Rennes, France
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Toulouse, France
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Bologna, Italy
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Florence, Italy
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Pavia, Italy
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Groningen, Netherlands
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Maastricht, Netherlands
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Utrecht, Netherlands
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Oslo, Norway
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Creixomil, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Viseu, Portugal
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Bilbao, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Gothenburg, Sweden
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Solna, Sweden
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Umeå, Sweden
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Taipei, Taiwan
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Bellshill, United Kingdom
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Birmingham, United Kingdom
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Cardiff, United Kingdom
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Hexham, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
Study team
Sponsor
Alnylam Pharmaceuticals
Study ID ALN-TTRSC02-007
Study director
Medical Director
Alnylam Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.