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ACTIVE NOT RECRUITING
NCT03997383
PHASE3

APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Sponsor: Alnylam Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.

Official title: APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran 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

360

Start Date

2019-09-12

Completion Date

2027-03-15

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Placebo

Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.

DRUG

Patisiran

Patisiran will be administered by intravenous (IV) infusion.

Locations (90)

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Los Angeles, California, United States

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Chicago, Illinois, United States

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Skokie, Illinois, United States

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Iowa City, Iowa, 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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Burlington, Massachusetts, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, 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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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Norfolk, Virginia, United States

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Buenos Aires, Buenos Aires, Argentina

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San Juan Bautista, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Buenos Aires, Argentina

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Westmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Box Hill, Victoria, Australia

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Liège, LIE, Belgium

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Hasselt, LIM, Belgium

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Aalst, OVL, Belgium

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Roeselare, WVL, Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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Ribeirão Preto, São Paulo, Brazil

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Ribeirão Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Sofia, Sofia-Grad, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Santiago, Chile

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Prague, Praha, Hlavní Mesto, Czechia

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Brno, Czechia

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Prague, Czechia

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Prague, Czechia

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Aarhus N, Aarhus, Denmark

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Copenhagen, Denmark

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Odense C, Denmark

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Clichy, Paris, France

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Créteil, Val-de-Marne, France

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Rennes, France

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Toulouse, France

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Lai Chi Kok, Hong Kong

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Bologna, Emilia-Romagna, Italy

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Messina, Sicily, Italy

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Florence, Italy

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Pavia, Italy

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Nagoya, Aichi-ken, Japan

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Kurume, Fukuoka, Japan

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Matsumoto, Nagano, Japan

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Suita, Osaka, Japan

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Bunkyo-ku, Tokyo, Japan

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Fukuoka, Japan

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Kumamoto, Japan

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Mexico City, Mexico

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Groningen, Netherlands

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Maastricht, Netherlands

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Christchurch, New Zealand

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Hamilton, New Zealand

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Lódz, Lódzkie, Poland

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Warsaw, Masovian Voivodeship, Poland

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Warsaw, Masovian Voivodeship, Poland

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Gdansk, Pomeranian Voivodeship, Poland

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Katowice, Silesian Voivodeship, Poland

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Porto, Portugal

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Senhora da Hora, Portugal

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Viseu, Portugal

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Seoul, South Korea

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Stockholm, Sweden

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Taipei, Taiwan

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Bellshill, Lanarkshire, United Kingdom

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London, London, City of, United Kingdom

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Hexham, Northumberland, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Cardiff, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom