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HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Sponsor: Alnylam Pharmaceuticals
Summary
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
Official title: HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
655
Start Date
2019-11-26
Completion Date
2027-01-13
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Vutrisiran
Vutrisiran will be administered by SC injection.
Sterile Normal Saline (0.9% NaCl)
Sterile normal saline (0.9% NaCl) will be administered by SC injection.
Locations (121)
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La Mesa, California, United States
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Los Angeles, 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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Gainesville, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, 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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Manhasset, 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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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Houston, Texas, United States
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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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Buenos Aires, Argentina
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Adelaide, Australia
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Darlinghurst, Australia
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Melbourne, Australia
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Northmead, Australia
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Woolloongabba, Australia
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Graz, Austria
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Vienna, Austria
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Vienna, Austria
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Brussels, Belgium
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Dendermonde, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Québec, Canada
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Toronto, Canada
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Bogotá D.C., Colombia
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Zagreb, Croatia
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Olomouc, Czechia
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Prague, Czechia
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Aarhus N, Denmark
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Odense, Denmark
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Créteil, France
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Marseille, France
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Paris, France
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Toulouse, France
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Essen, Germany
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Frankfurt am Main, Germany
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Göttingen, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Münster, Germany
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Würzburg, Germany
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Budapest, Hungary
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Budapest, Hungary
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Szeged, Hungary
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Dublin, Ireland
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Dublin, Ireland
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Bunkyō City, Japan
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Bunkyō City, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Kashihara, Japan
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Kita-gun, Japan
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Kumamoto, Japan
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Kurume, Japan
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Matsumoto, Japan
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Nankoku, Japan
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Shinjuku-Ku, Japan
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Suita, Japan
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Suita, Japan
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Tsurumai-cho, Japan
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Riga, Latvia
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Hamra, Lebanon
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Kaunas, Lithuania
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Kuantan, Malaysia
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Sungai Buloh, Malaysia
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Chisinau, Moldova
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Eindhoven, Netherlands
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Groningen, Netherlands
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Utrecht, Netherlands
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Oslo, Norway
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Callao - Vellavista, Peru
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Lima - San Miguel, Peru
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San Isidro, Peru
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Cracow, Poland
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Gdansk, Poland
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Katowice, Poland
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Lodz, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Coimbra, Portugal
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Faro, Portugal
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Guimarães, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Mecca, Saudi Arabia
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Riyadh, Saudi Arabia