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ACTIVE NOT RECRUITING
NCT04153149
PHASE3

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Sponsor: Alnylam Pharmaceuticals

View on ClinicalTrials.gov

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

2026-12-02

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Vutrisiran

Vutrisiran will be administered by SC injection.

DRUG

Sterile Normal Saline (0.9% NaCl)

Sterile normal saline (0.9% NaCl) will be administered by SC injection.

Locations (119)

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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, Ciudad Autónoma de BuenosAires, Argentina

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Buenos Aires, Pilar, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Darlinghurst, New South Wales, Australia

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Northmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Melbourne, Victoria, Australia

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Graz, Austria

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Vienna, Austria

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Vienna, Austria

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Dendermonde, Oost-Vlaanderen, Belgium

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Ghent, Oost-Vlaanderen, Belgium

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Brussels, Belgium

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Leuven, Belgium

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Zagreb, Croatia

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Olomouc, Olomoucký kraj, Czechia

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Prague, Praha, Hlavní Mesto, Czechia

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Odense, Region Syddanmark, Denmark

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Aarhus N, 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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Frankfurt am Main, Hesse, Germany

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Leipzig, Saxony, Germany

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Essen, Germany

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Göttingen, Germany

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Heidelberg, 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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Tsurumai-cho, Aichi-ken, Japan

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Fukuoka, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Kita-gun, Kagawa-ken, Japan

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Nankoku, Kochi, Japan

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Matsumoto, Nagano, Japan

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Kashihara, Nara, Japan

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Suita, Osaka, Japan

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Suita, Osaka, Japan

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Bunkyo-ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Shinjuku-Ku, Tokyo, Japan

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Fukuoka, Japan

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Kumamoto, Japan

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Riga, Latvia

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Hamra, Beyrouth, Lebanon

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Kaunas, Lithuania

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Kuantan, Pahang, Malaysia

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Sungai Buloh, Selangor, 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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San Isidro, Lima region, Peru

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Lima, Peru

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Wroclaw, Lower Silesian Voivodeship, Poland

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Lodz, Lódzkie, Poland

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Warsaw, Masovian Voivodeship, Poland

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Gdansk, Pomeranian Voivodeship, Poland

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Katowice, Poland

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Lisbon, Lisbon District, Portugal

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Coimbra, Portugal

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Faro, Portugal

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Guimarães, Portugal

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Porto, Portugal

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Mecca, Mecca Region, Saudi Arabia

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Riyadh, Saudi Arabia

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Ljubljana, Slovenia

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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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Seoul, South Korea

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L'Hospitalet de Llobregat, Barcelona, Spain

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Majadahonda, Madrid, Spain

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Barcelona, Spain

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Bilbao, Spain

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Huelva, Spain

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Málaga, Spain

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Göteborg, Västerbotten County, Sweden

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Gothenburg, Sweden

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Chiang Mai, Thailand

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Bellshill, Lanarkshire, United Kingdom

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London, London, City of, United Kingdom

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Londonderry, Londonderry, United Kingdom

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Hexham, Northumberland, United Kingdom

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Birmingham, United Kingdom

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Cardiff, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom