NCT05667493Enrolling by invitationPhase 3
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1400 (estimated)
- First submitted
- 12 Jul 2022
- Start date
- 30 Nov 2022
- Primary completion date
- Aug 2029
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Diseases
- Amyloidosis
- NCT number
- NCT05667493
- EudraCT number
- 2022-000826-74
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1400
- From 30 Nov 2022 to the primary completion date, Aug 2029
- 132 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
- 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.
Who the study is looking for
- Satisfactory completion of Treatment Period and the End of Treatment Visit of the Index Study (ION-682884-CS2) OR diagnosis of ATTR-CM and satisfactory participation on ISIS 420915- CS101 study as judged by the Investigator and Sponsor.
- Investigator is willing to treat the participant with open-label eplontersen.
- Willingness to adhere to vitamin A supplementation per protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (132)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Cardiovascular de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Box Hill Hospital Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Advara HeartCare Joondalup Coordinator of this site? Confirm its status | Joondalup | Australia | Unknown status |
| Advara HeartCare Coordinator of this site? Confirm its status | Joondalup | Australia | Unknown status |
| Advara HeartCare Leabrook Coordinator of this site? Confirm its status | Leabrook | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Advara HeartCare Murdoch Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg - Campus Sint-Jan Coordinator of this site? Confirm its status | Limbourg | Belgium | Unknown status |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Instituto Dante Pazzanese de Cardiologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Universidade Estadual de Campinas Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| A Beneficência Portuguesa de São Paulo - Unidade Mirante Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto do Coração de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University Hospital - London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hôpital régional de Rimouski Coordinator of this site? Confirm its status | Rimouski | Canada | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Gordon and Leslie Diamond Health Care Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Fakultni nemocnice u sv. Anny v Brne Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Institut klinicke a experimentalni mediciny Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Uniklinik Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitaetsklinikum Heidelberg - Zentrum für Innere Medizin Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitätsklinikum des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Complejo Hospitalario Universitario de Santiago (CHUS) Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hôpitaux Universitaires Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre Hospitalier Départemental Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Hopital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| AES - Synexus - Scotland Clinical Research Centre Coordinator of this site? Confirm its status | Bellshill | United Kingdom | Unknown status |
| AES - Synexus - Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| AES - Synexus - Midlands Coordinator of this site? Confirm its status | Edgbaston | United Kingdom | Unknown status |
| Royal Free London NHS Foundation Trust Coordinator of this site? Confirm its status | Hampstead | United Kingdom | Unknown status |
| Synexus Merseyside Clinical Research Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Richmond Pharmacology Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Synexus Manchester Clinical Research Centre Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Synexus - Merseyside Clinical Research Centre Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda Ospedale Università di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Sant'Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Saiseikai Fukuoka General Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hamamatsu University Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Unknown status |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume-shi | Japan | Unknown status |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka Metropolitan University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Keio University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II Coordinator of this site? Confirm its status | Kraków | Poland | Unknown status |
| Unidade Local de Saude do Alto Ave, E. P. E (Hospital da Senhora da Oliveira Guimaraes) Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| Hospital da Senhora da Oliveira Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| Unidade Local de Saúde de São José, E. P. E - Hospital de Santa Marta Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Unidade Local de Saude de Santo Antonio, E. P. E - Hospital Geral de Santo Antonio Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Unidade Local de Saúde de São João, EPE Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Centro Hospitalar Universitário de São João Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Sahlgrenska Universitetssjukhuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Skellefteå lasarett Coordinator of this site? Confirm its status | Skellefteå | Sweden | Unknown status |
| Emory Heart and Vascular Center - Emory Clifton Campus Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Piedmont Heart of Fayetteville Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Hospital - Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boston University School of Medicine Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Carl and Edyth Lindner Research Center at The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University College of Medicine Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Piedmont Atlanta Hospital Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kansas Medical Center (KUMC) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Altman Clinical and Translational Research Institute - Center for Clinical Research Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Lancaster General Hospital Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Allina Health Minneapolis Heart Institute - Abbott Northwestern's Heart Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt Heart and Vascular Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| New York University Langone Cardiology Associates Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medicine Cardiology Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Penn Presbyterian Medical Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University Of California San Francisco Urology Practice Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Stanford University (Leland Stanford Junior University) Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.