Long-Term Safety of Eplontersen for Transthyretin Amyloid Heart Disease
Studies long-term safety of eplontersen in adults with transthyretin amyloid heart disease.
Plain-language title generated from the registry record
Registry title: An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Key facts
- Where
- Calgary, London, Montreal, Rimouski, Toronto, and Vancouver, CanadaSee the 6 sites
- Phase
- Phase 3
Where in Canada
- University Of CalgaryCalgary, CanadaNo longer taking part
- University Hospital - London Health Sciences CentreLondon, CanadaNo longer taking part
- Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, CanadaNo longer taking part
- Hôpital régional de RimouskiRimouski, CanadaNo longer taking part
- Toronto General HospitalToronto, CanadaNo longer taking part
- Gordon and Leslie Diamond Health Care CentreVancouver, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ionis Pharmaceuticals, Inc.
- Trial code
- NCT05667493
- Record updated
- 17 April 2026
- Original description
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.Read full original descriptionShow less
An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
Inclusion: 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.
Exclusion: 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.