clinical trial · NCT05667493
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Ionis Pharmaceuticals, Inc.·phase3·enrolling by invitation·n = 1,400
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)Eplontersen
brief summary
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
started
Nov 30, 2022
primary completion
Aug 1, 2029
completion
Aug 1, 2029
last updated
Apr 17, 2026
detailed description
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.
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol