Transthyretin Amyloid Cardiomyopathy Clinical Trial

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

Summary

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

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Full Description

This is a multicenter, open-label, Phase 3 study in up to approximately 1400 participants. Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A. This study will consist of the following periods: less than or equal to (≤) 10-week screening assessment period, up to 36-month treatment period, and up to 6-month post-treatment evaluation period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

1400

Study ID:

NCT05667493

Recruitment Status:

Recruiting

Sponsor:

Ionis Pharmaceuticals, Inc.

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There are 25 Locations for this study

See Locations Near You

Mayo Clinic
Scottsdale Arizona, 85259, United States
Altman Clinical and Translational Research Institute - Center for Clinical Research
La Jolla California, 92037, United States
University of Colorado Hospital - Anschutz Medical Campus
Aurora Colorado, 80045, United States
Piedmont Heart of Fayetteville
Atlanta Georgia, 30309, United States
Indiana University Health University Hospital
Indianapolis Indiana, 46202, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
New York University Langone Cardiology Associates
New York New York, 10016, United States
Columbia University Irving Medical Center
New York New York, 10034, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
University of Utah
Salt Lake City Utah, 84112, United States
Liverpool Hospital
Liverpool , 2170, Australia
Medizinische Universität Innsbruck
Innsbruck , 6020, Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Brugge , 8000, Belgium
University of Calgary
Calgary Alberta, T2N 4, Canada
Universitätsklinikum des Saarlandes
Homburg , 66421, Germany
Universitätsklinikum Münster
Münster , 48149, Germany
Rambam Health Care Campus
Haifa , 31096, Israel
Kaplan Medical Center
Rehovot , 76610, Israel
Azienda Ospedaliero - Universitaria Careggi
Firenze , 50134, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Hospital da Senhora da Oliveira
Guimarães , 4835-, Portugal
Sahlgrenska Universitetssjukhuset
Göteborg , 413 4, Sweden
Skellefteå lasarett
Skellefteå , 931 8, Sweden

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

1400

Study ID:

NCT05667493

Recruitment Status:

Recruiting

Sponsor:


Ionis Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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