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

Description

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

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Talk to us

Study Overview

On this page

Study Details

Study overview

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with 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)

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

Condition
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic, Scottsdale, Arizona, United States, 85259

Beverly Hills

Cedars-Sinai Medical Center, Beverly Hills, California, United States, 90211

La Jolla

Altman Clinical and Translational Research Institute - Center for Clinical Research, La Jolla, California, United States, 92037

Stanford

Stanford University (Leland Stanford Junior University), Stanford, California, United States, 94305

Aurora

University of Colorado Hospital - Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Washington

The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion, Washington, District of Columbia, United States, 20037

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Atlanta

Piedmont Heart of Fayetteville, Atlanta, Georgia, United States, 30309

Atlanta

Emory Heart and Vascular Center - Emory Clifton Campus, Atlanta, Georgia, United States, 30322

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ionis Pharmaceuticals, Inc.,

Study Record Dates

2029-08