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 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.
This is a multicenter, open-label extension, Phase 3 study in up to approximately 1400 participants from the 682884-CS2 study. Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or until 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.
Inclusion Criteria:
Exclusion Criteria:
La Jolla, California 92037, United States
San Francisco, California 94143, United States
Washington D.C., District of Columbia 20037, United States
Minneapolis, Minnesota 55407, United States
Kurume-Shi, Fukuoka 830-0011, Japan
Shinjuku-Ku, 160-8582, Japan
Guimarães, 4835-044, Portugal
Porto, 4099-001, Portugal
Bellshill, England ML4 3NJ, United Kingdom