ENROLLING_BY_INVITATION

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

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Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)Amyloidosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Quick Facts

Study Start:2022-11-30
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT05667493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Investigator is willing to treat the participant with open-label eplontersen.
  3. 3. Willingness to adhere to vitamin A supplementation per protocol.
  1. 1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
  2. 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.

Contacts and Locations

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
United States
Altman Clinical and Translational Research Institute - Center for Clinical Research
La Jolla, California, 92037
United States
Stanford University (Leland Stanford Junior University)
Stanford, California, 94305
United States
University of Colorado Hospital - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion
Washington, District of Columbia, 20037
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Piedmont Heart of Fayetteville
Atlanta, Georgia, 30309
United States
Emory Heart and Vascular Center - Emory Clifton Campus
Atlanta, Georgia, 30322
United States
Piedmont Atlanta Hospital
Fayetteville, Georgia, 30214
United States
Northwestern University
Chicago, Illinois, 60611
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Boston University School of Medicine
Boston, Massachusetts, 02118
United States
Allina Health Minneapolis Heart Institute - Abbott Northwestern's Heart Hospital
Minneapolis, Minnesota, 55407
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
New York University Langone Cardiology Associates
New York, New York, 10016
United States
Weill Cornell Medicine Cardiology
New York, New York, 10021
United States
Columbia University Irving Medical Center
New York, New York, 10034
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Carl and Edyth Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
United States
The Ohio State University College of Medicine
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
University of Washington
Seattle, Washington, 98195
United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Ionis Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-30
Study Completion Date2029-08

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

  • Amyloidosis

Additional Relevant MeSH Terms

  • Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)