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ENROLLING BY INVITATION
NCT05667493
PHASE3

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Sponsor: Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

Official title: An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2022-11-30

Completion Date

2029-08

Last Updated

2025-12-12

Healthy Volunteers

No

Interventions

DRUG

Eplontersen

Eplontersen will be administered by SC injection.

Locations (122)

Mayo Clinic

Scottsdale, Arizona, United States

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Altman Clinical and Translational Research Institute - Center for Clinical Research

La Jolla, California, United States

University Of California San Francisco Urology Practice

San Francisco, California, United States

Stanford University (Leland Stanford Junior University)

Stanford, California, United States

University of Colorado Hospital - Anschutz Medical Campus

Aurora, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

Washington D.C., District of Columbia, United States

Cleveland Clinic Florida

Weston, Florida, United States

Piedmont Heart of Fayetteville

Atlanta, Georgia, United States

Emory Heart and Vascular Center - Emory Clifton Campus

Atlanta, Georgia, United States

Piedmont Atlanta Hospital

Fayetteville, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Allina Health Minneapolis Heart Institute - Abbott Northwestern's Heart Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

New York University Langone Cardiology Associates

New York, New York, United States

Weill Cornell Medicine Cardiology

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Carl and Edyth Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

The Ohio State University College of Medicine

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina

Advara HeartCare

Joondalup, Western Australia, Australia

Advara HeartCare Murdoch

Murdoch, Western Australia, Australia

Box Hill Hospital

Clayton, Australia

Royal Hobart Hospital

Hobart, Australia

Advara HeartCare - Joondalup

Joondalup, Australia

Liverpool Hospital

Liverpool, Australia

Advara HeartCare Murdoch

Murdoch, Australia

Westmead Hospital

Westmead, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Medizinische Universität Graz

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Medizinische Universität Wien

Vienna, Austria

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, Belgium

Ziekenhuis Oost-Limburg - Campus Sint-Jan

Limbourg, Belgium

Hospital Moinhos de Vento

Porto Alegre, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, Brazil

A Beneficência Portuguesa de São Paulo - Unidade Mirante

São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Instituto do Coração de São Paulo

São Paulo, Brazil

Universidade Estadual de Campinas

São Paulo, Brazil

Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED

São Paulo, Brazil

University of Calgary

Calgary, Alberta, Canada

University Hospital - London Health Sciences Centre

London, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Hôpital Regional de Rimouski

Rimouski, Canada

Gordon and Leslie Diamond Health Care Centre

Vancouver, Canada

Fakultní Nemocnice u sv. Anny v Brně

Brno, Czechia

Vseobecna Fakultni Nemocnice v Praze

Prague, Czechia

Institut Klinické a Experimentální Medicíny

Prague, Czechia

Rigshospitalet

Copenhagen, Denmark

Hôpitaux Universitaires Henri Mondor

Créteil, France

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Hôpital de la Timone

Marseille, France

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

Nantes, France

Hôpital Haut-Lévêque

Pessac, France

Hôpital Rangueil

Toulouse, France

Uniklinik Köln

Cologne, Germany

Universitaetsklinikum Heidelberg - Zentrum für Innere Medizin

Heidelberg, Germany

Universitätsklinikum des Saarlandes

Homburg, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

General Hospital of Athens "Alexandra"

Athens, Greece

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Kaplan Medical Center

Rehovot, Israel

Azienda Ospedaliero Universitaria Delle Marche

Ancona, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Azienda Ospedale Università di Padova

Padova, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica

Pisa, Italy

Azienda Ospedaliera - Universitaria Sant' Andrea

Roma, Italy

Kurume University Hospital

Kurume-Shi, Fukuoka, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, Hukuoka [Fukuoka], Japan

Kumamoto University Hospital

Kumamoto, Japan

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, Poland

Hospital da Senhora da Oliveira

Guimarães, Portugal

Unidade Local de Saúde do Alto Ave, E. P. E (Hospital da Senhora da Oliveira Guimarães)

Guimarães, Portugal

Unidade Local de Saúde de São José, E. P. E - Hospital de Santa Marta

Lisbon, Portugal

Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio

Porto, Portugal

Unidade Local de Saúde de Santo António, E. P. E - Hospital Geral de Santo Antonio

Porto, Portugal

Centro Hospitalar Universitário de São João

Porto, Portugal

Unidade Local de Saúde de São João, EPE

Porto, Portugal

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Skellefteå lasarett

Skellefteå, Sweden

AES - Synexus - Scotland Clinical Research Centre

Bellshill, England, United Kingdom

AES - Synexus - Midlands

Edgbaston, England, United Kingdom

Synexus - Manchester Clinical Research Centre

Manchester, England, United Kingdom

AES - Synexus - Wales

Cardiff, Wales, United Kingdom

Royal Free London NHS Foundation Trust

Hampstead, United Kingdom

Richmond Pharmacology

London, United Kingdom