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

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

Phase

3

Condition

Circulation Disorders

Amyloidosis

Treatment

Sterile Normal Saline (0.9% NaCl)

Vutrisiran

Clinical Study ID

NCT04153149
ALN-TTRSC02-003
2019-003153-28
2023-508366-15
  • Ages 18-85
  • All Genders

Study 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 patients with ATTR amyloidosis with cardiomyopathy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy,classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy orwild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specifieddiagnostic criteria

  • Has medical history of heart failure (HF) with at least 1 prior hospitalization forHF OR clinical evidence of HF

Exclusion

Exclusion Criteria:

  • Has known primary amyloidosis or leptomeningeal amyloidosis

  • Has New York Heart Association (NYHA) Class IV heart failure

  • Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria

  • Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit

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

  • Has received prior TTR-lowering treatment

  • Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due tovalvular heart disease, or cardiomyopathy due to ischemic heart disease

Study Design

Total Participants: 655
Treatment Group(s): 2
Primary Treatment: Sterile Normal Saline (0.9% NaCl)
Phase: 3
Study Start date:
November 26, 2019
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • Clinical Trial Site

    Buenos Aires,
    Argentina

    Site Not Available

  • Clinical Trial Site

    Adelaide,
    Australia

    Site Not Available

  • Clinical Trial Site

    Melbourne,
    Australia

    Site Not Available

  • Clinical Trial Site

    Sydney,
    Australia

    Site Not Available

  • Clinical Trial Site

    Westmead,
    Australia

    Site Not Available

  • Clinical Trial Site

    Woolloongabba,
    Australia

    Site Not Available

  • Clinical Trial Site

    Graz,
    Austria

    Site Not Available

  • Clinical Trial Site

    Vienna,
    Austria

    Site Not Available

  • Clinical Trial Site

    Anderlecht,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Dendermonde,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Ghent,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Leuven,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Quebec City,
    Canada

    Site Not Available

  • Clinical Trial Site

    Toronto,
    Canada

    Site Not Available

  • Clinical Trial Site

    Bogotá,
    Colombia

    Site Not Available

  • Clinical Trial Site

    Zagreb,
    Croatia

    Site Not Available

  • Clinical Trial Site

    Olomouc,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Prague,
    Czechia

    Site Not Available

  • Clinical Trial Site

    Aarhus,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Odense,
    Denmark

    Site Not Available

  • Clinical Trial Site

    Créteil,
    France

    Site Not Available

  • Clinical Trial Site

    Marseille,
    France

    Site Not Available

  • Clinical Trial Site

    Paris,
    France

    Site Not Available

  • Clinical Trial Site

    Toulouse,
    France

    Site Not Available

  • Clinical Trial Site

    Essen,
    Germany

    Site Not Available

  • Clinical Trial Site

    Göttingen,
    Germany

    Site Not Available

  • Clinical Trial Site

    Heidelberg,
    Germany

    Site Not Available

  • Clinical Trial Site

    Leipzig,
    Germany

    Site Not Available

  • Clinical Trial Site

    Münster,
    Germany

    Site Not Available

  • Clinical Trial Site

    Würzburg,
    Germany

    Site Not Available

  • Clinical Trial Site

    Budapest,
    Hungary

    Site Not Available

  • Clinical Trial Site

    Szeged,
    Hungary

    Site Not Available

  • Clinical Trial Site

    Dublin,
    Ireland

    Site Not Available

  • Clinical Trial Site

    Haifa,
    Israel

    Site Not Available

  • Clinical Trial Site

    Jerusalem,
    Israel

    Site Not Available

  • Clinical Trial Site

    Ramat Gan,
    Israel

    Site Not Available

  • Clinical Trial Site

    Aichi,
    Japan

    Site Not Available

  • Clinical Trial Site

    Fukuoka,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kagawa,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kashihara,
    Japan

    Site Not Available

  • Clinical Trial Site

    Kumamoto,
    Japan

    Site Not Available

  • Clinical Trial Site

    Matsumoto,
    Japan

    Site Not Available

  • Clinical Trial Site

    Nankoku,
    Japan

    Site Not Available

  • Clinical Trial Site

    Osaka,
    Japan

    Site Not Available

  • Clinical Trial Site

    Tokyo,
    Japan

    Site Not Available

  • Clinical Trial Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Riga,
    Latvia

    Site Not Available

  • Clinical Trial Site

    Beirut,
    Lebanon

    Site Not Available

  • Clinical Trial Site

    Kaunas,
    Lithuania

    Site Not Available

  • Clinical Trial Site

    Kuantan,
    Malaysia

    Site Not Available

  • Clinical Trial Site

    Shah Alam,
    Malaysia

    Site Not Available

  • Clinical Trial Site

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • Clinical Trial Site

    Eindhoven,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Groningen,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Utrecht,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Oslo,
    Norway

    Site Not Available

  • Clinical Trial Site

    Callao,
    Peru

    Site Not Available

  • Clinical Trial Site

    Lima,
    Peru

    Site Not Available

  • Clinical Trial Site

    San Miguel,
    Peru

    Site Not Available

  • Clinical Trial Site

    Gdańsk,
    Poland

    Site Not Available

  • Clinical Trial Site

    Katowice,
    Poland

    Site Not Available

  • Clinical Trial Site

    Kraków,
    Poland

    Site Not Available

  • Clinical Trial Site

    Warszawa,
    Poland

    Site Not Available

  • Clinical Trial Site

    Wrocław,
    Poland

    Site Not Available

  • Clinical Trial Site

    Łódź,
    Poland

    Site Not Available

  • Clinical Trial Site

    Coimbra,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Faro,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Guimarães,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Lisboa,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Porto,
    Portugal

    Site Not Available

  • Clinical Trial Site

    Makkah,
    Saudi Arabia

    Site Not Available

  • Clinical Trial Site

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Clinical Trial Site

    Ljubljana,
    Slovenia

    Site Not Available

  • Clinical Trial Site

    Barcelona,
    Spain

    Site Not Available

  • Clinical Trial Site

    Bilbao,
    Spain

    Site Not Available

  • Clinical Trial Site

    Huelva,
    Spain

    Site Not Available

  • Clinical Trial Site

    Madrid,
    Spain

    Site Not Available

  • Clinical Trial Site

    Málaga,
    Spain

    Site Not Available

  • Clinical Trial Site

    Gothenburg,
    Sweden

    Site Not Available

  • Clinical Trial Site

    Umeå,
    Sweden

    Site Not Available

  • Clinical Trial Site

    Chiang Mai,
    Thailand

    Site Not Available

  • Clinical Trial Site

    Birmingham,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Cardiff,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Glasgow,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    London,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Londonderry,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Middlesbrough,
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Clinical Trial Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Clinical Trial Site

    Stanford, California 94305
    United States

    Site Not Available

  • Clinical Trial Site

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Clinical Trial Site

    Gainesville, Georgia 30501
    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

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Clinical Trial Site

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Clinical Trial Site

    Manhasset, New York 11030
    United States

    Site Not Available

  • Clinical Trial Site

    New York, New York 10032
    United States

    Site Not Available

  • Clinical Trial Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Clinical Trial Site

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Trial Site

    Houston, Texas 77030
    United States

    Site Not Available

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