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

Last updated: November 13, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Amyloidosis

Circulation Disorders

Treatment

Placebo

Patisiran

Clinical Study ID

NCT03997383
ALN-TTR02-011
2019-001458-24
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as eitherhereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis withcardiomyopathy

  • Medical history of heart failure with at least 1 prior hospitalization for heartfailure, or current clinical evidence (signs and symptoms of heart failure)

  • Clinically stable with no cardiovascular related hospitalizations within 6 weeks ofstudy start

  • Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6months with evidence of disease progression while on tafamidis treatment

  • Able to complete ≥150 m on the 6-minute walk test

  • Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker ofheart failure severity, >300 ng/L and <8500 ng/L; in participants with permanent orpersistent atrial fibrillation, screening NT-proBNP> 600 ng/L and <8500 ng/L

Exclusion

Exclusion Criteria:

  • Known primary amyloidosis (AL) or leptomeningeal amyloidosis.

  • Received prior TTR lowering treatment

  • New York Heart Association heart failure classification of III and at high risk

  • New York Heart Association heart failure classification of IV

  • Neuropathy requiring cane or stick to walk, or is wheelchair bound

  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2

  • Abnormal liver function

  • Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

  • Has non-amyloid disease that significantly affects ability to walk (e.g., severechronic obstructive pulmonary disease, severe arthritis, or peripheral vasculardisease affecting ambulation)

  • Prior or planned heart, liver, or other organ transplant

  • Other cardiomyopathy not related to ATTR amyloidosis

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 04, 2019
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • Clinical Trial Site

    Buenos Aires,
    Argentina

    Site Not Available

  • Clinical Trial Site

    Córdoba,
    Argentina

    Site Not Available

  • Clinical Trial Site

    Córdoba 3860259,
    Argentina

    Site Not Available

  • Clinical Trial Site

    Florencio Varela,
    Argentina

    Site Not Available

  • Clinical Trial Site

    Rosario, S2000PBJ
    Argentina

    Site Not Available

  • Clinical Trial Site

    Rosario 3838583, S2000DSR
    Argentina

    Site Not Available

  • Clinical Trial Site

    Santa Fe,
    Argentina

    Site Not Available

  • Clinical Trial Site

    Box Hill,
    Australia

    Site Not Available

  • Clinical Trial Site

    Box Hill 2174360,
    Australia

    Site Not Available

  • Clinical Trial Site

    Westmead,
    Australia

    Site Not Available

  • Clinical Trial Site

    Westmead 2143973,
    Australia

    Site Not Available

  • Clinical Trial Site

    Woolloongabba,
    Australia

    Site Not Available

  • Clinical Trial Site

    Aalst,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Aalst 2803448,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Hasselt,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Hasselt 2796491,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Liège,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Liège 2792413,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Roeselare,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Roeselare 2787889,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Porto Alegre,
    Brazil

    Site Not Available

  • Clinical Trial Site

    Porto Alegre 3452925,
    Brazil

    Site Not Available

  • Clinical Trial Site

    Ribeirão Preto,
    Brazil

    Site Not Available

  • Clinical Trial Site

    Ribeirão Preto 3451328,
    Brazil

    Site Not Available

  • Clinical Trial Site

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Clinical Trial Site

    Rio de Janeiro 3451190,
    Brazil

    Site Not Available

  • Clinical Trial Site

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Clinical Trial Site

    São Paulo 3448439, 14048-900
    Brazil

    Site Not Available

  • Clinical Trial Site

    Sofia,
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Stara Zagora,
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Santiago,
    Chile

    Site Not Available

  • Clinical Trial Site

    Santiago 3871336,
    Chile

    Site Not Available

  • Clinical Trial Site

    Brno,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Brno 3078610,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Prague,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Prague 3067696,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Praha,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Praha 2,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Aarhus,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Aarhus 2624652,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Copenhagen,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Copenhagen 2618425,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Odense,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Odense 2615876,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Créteil,
    France

    Site Not Available

  • Clinical Trial Site

    Créteil 3022530,
    France

    Site Not Available

  • Clinical Trial Site

    Paris,
    France

    Site Not Available

  • Clinical Trial Site

    Rennes,
    France

    Site Not Available

  • Clinical Trial Site

    Rennes 2983990,
    France

    Site Not Available

  • Clinical Trial Site

    Toulouse,
    France

    Site Not Available

  • Clinical Trial Site

    Toulouse 2972315,
    France

    Site Not Available

  • Clinical Trial Site

    Lai Chi Kok,
    Hong Kong

    Site Not Available

  • Clinical Trial Site

    Lai Chi Kok 1819567,
    Hong Kong

    Site Not Available

  • Clinical Trial Site

    Bologna,
    Italy

    Site Not Available

  • Clinical Trial Site

    Bologna 3181928,
    Italy

    Site Not Available

  • Clinical Trial Site

    Firenze,
    Italy

    Site Not Available

  • Clinical Trial Site

    Florence 3176959,
    Italy

    Site Not Available

  • Clinical Trial Site

    Messina,
    Italy

    Site Not Available

  • Clinical Trial Site

    Messina 2524170,
    Italy

    Site Not Available

  • Clinical Trial Site

    Pavia,
    Italy

    Site Not Available

  • Clinical Trial Site

    Pavia 3171366,
    Italy

    Site Not Available

  • Clinical Trial Site

    Fukuoka,
    Japan

    Site Not Available

  • Clinical Trial Site

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kumamoto,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kumamoto 1858421,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kurume,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kurume 1858088,
    Japan

    Site Not Available

  • Clinical Trial Site

    Matsumoto,
    Japan

    Site Not Available

  • Clinical Trial Site

    Matsumoto 1857519,
    Japan

    Site Not Available

  • Clinical Trial Site

    Nagoya,
    Japan

    Site Not Available

  • Clinical Trial Site

    Nagoya 1856057,
    Japan

    Site Not Available

  • Clinical Trial Site

    Osaka,
    Japan

    Site Not Available

  • Clinical Trial Site

    Osaka 1853909,
    Japan

    Site Not Available

  • Clinical Trial Site

    Tokyo,
    Japan

    Site Not Available

  • Clinical Trial Site

    Tokyo 1850147,
    Japan

    Site Not Available

  • Clinical Trial Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Mexico City,
    Mexico

    Site Not Available

  • Clinical Trial Site

    Mexico City 3530597,
    Mexico

    Site Not Available

  • Clinical Trial Site

    Groningen,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Groningen 2755251,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Maastricht,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Maastricht 2751283,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Christchurch,
    New Zealand

    Site Not Available

  • Clinical Trial Site

    Christchurch 2192362,
    New Zealand

    Site Not Available

  • Clinical Trial Site

    Hamilton,
    New Zealand

    Site Not Available

  • Clinical Trial Site

    Hamilton 2190324,
    New Zealand

    Site Not Available

  • Clinical Trial Site

    Gdańsk,
    Poland

    Site Not Available

  • Clinical Trial Site

    Katowice,
    Poland

    Site Not Available

  • Clinical Trial Site

    Warszawa,
    Poland

    Site Not Available

  • Clinical Trial Site

    Łódź,
    Poland

    Site Not Available

  • Clinical Trial Site

    Porto,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Senhora Da Hora,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Viseu,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Viseu 2732265,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Seoul 1835848,
    South Korea

    Site Not Available

  • Clinical Trial Site

    Stockholm,
    Sweden

    Site Not Available

  • Clinical Trial Site

    Stockholm 2673730,
    Sweden

    Site Not Available

  • Clinical Trial Site

    Taipei,
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Taipei 1668341,
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Birmingham,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Birmingham 2655603,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Cardiff,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Cardiff 2653822,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Glasgow,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Glasgow 2648579,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    London,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    London 2643743,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester 2643123,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Stockton-on-Tees,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Stockton-on-Tees 2636876,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • Clinical Trial Site

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Clinical Trial Site

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Clinical Trial Site

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • Clinical Trial Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Clinical Trial Site

    Kansas City, Kansas 66103
    United States

    Site Not Available

  • Clinical Trial Site

    Kansas City 4273837, Kansas 4273857 66103
    United States

    Site Not Available

  • Clinical Trial Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Clinical Trial Site

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Clinical Trial Site

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Clinical Trial Site

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Clinical Trial Site

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

  • Clinical Trial Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Clinical Trial Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Clinical Trial Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Clinical Trial Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Clinical Trial Site

    New York, New York 10034
    United States

    Site Not Available

  • Clinical Trial Site

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Clinical Trial Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Clinical Trial Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Clinical Trial Site

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Clinical Trial Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • Clinical Trial Site

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • Clinical Trial Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.