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Clinical Trials in Germany / NCT05667493
Enrolling by invitation Phase 3

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

NCT05667493 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2022-11-30
Last updated
2026-04-17

Condition(s) studied

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Investigational drug(s) / intervention(s)

Eplontersen →

Eplontersen: Eplontersen will be administered by SC injection.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Investigator is willing to treat the participant with open-label eplontersen. 3. Willingness to adhere to vitamin A supplementation per protocol. Exclusion Criteria: 1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study). 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.

Primary outcome measure(s)

Trial sites (134)

FacilityCityRegionStatus
Mayo Clinic Scottsdale Arizona
Cedars-Sinai Medical Center Beverly Hills California
Altman Clinical and Translational Research Institute - Center for Clinical Research La Jolla California
University Of California San Francisco Urology Practice San Francisco California
Stanford University (Leland Stanford Junior University) Stanford California
University of Colorado Hospital - Anschutz Medical Campus Aurora Colorado
MedStar Washington Hospital Center Washington D.C. District of Columbia
The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion Washington D.C. District of Columbia
Cleveland Clinic Florida Weston Florida
Piedmont Heart of Fayetteville Atlanta Georgia
Emory Heart and Vascular Center - Emory Clifton Campus Atlanta Georgia
Piedmont Atlanta Hospital Fayetteville Georgia
Northwestern University Chicago Illinois
Loyola University Medical Center Maywood Illinois
Indiana University Health University Hospital Indianapolis Indiana
University of Kansas Medical Center (KUMC) Kansas City Kansas
University of Kansas Medical Center Kansas City Kansas
University of Maryland Medical Center Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Boston University School of Medicine Boston Massachusetts
Henry Ford Health System Detroit Michigan
Allina Health Minneapolis Heart Institute - Abbott Northwestern's Heart Hospital Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Saint Luke's Hospital of Kansas City Kansas City Missouri
Barnes-Jewish Hospital St Louis Missouri
New York University Langone Cardiology Associates New York New York
Weill Cornell Medicine Cardiology New York New York
Columbia University Irving Medical Center New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Duke University Medical Center Durham North Carolina
Carl and Edyth Lindner Research Center at The Christ Hospital Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Cleveland Clinic Main Campus Cleveland Ohio
The Ohio State University College of Medicine Columbus Ohio
Oregon Health and Science University Portland Oregon
Lancaster General Hospital Lancaster Pennsylvania
Penn Presbyterian Medical Center Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
Vanderbilt Heart and Vascular Institute Nashville Tennessee

+ 94 more sites — see the full list on the official registry below.

More Ionis Pharmaceuticals, Inc. trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05667493 on ClinicalTrials.gov ↗ ← All trials in Germany