An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
NCT ID: NCT05667493
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
1400 participants
INTERVENTIONAL
2022-11-30
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eplontersen
Eplontersen will be administered once every month by sub-cutaneous (SC) injection for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first.
Eplontersen
Eplontersen will be administered by SC injection.
Interventions
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Eplontersen
Eplontersen will be administered by SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Investigator is willing to treat the participant with open-label eplontersen.
3. Willingness to adhere to vitamin A supplementation per protocol.
Exclusion Criteria
2. Have any new condition or worsening of an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Padua, , 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
Countries
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Other Identifiers
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2022-000826-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ION-682884-CS12
Identifier Type: -
Identifier Source: org_study_id
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