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

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM) Clinical Trial

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)

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

This is a multicenter, open-label, Phase 3 study in up to approximately 1400 participants. Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or 6 months 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. This study will consist of the following periods: less than or equal to (≤) 10-week screening assessment period, up to 36-month treatment period, and up to 6-month post-treatment evaluation period. ;

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

• NCT number: NCT05667493
• Study type: Interventional
• Source: Ionis Pharmaceuticals, Inc.
• Contact: Ionis Pharmaceuticals
• Phone: (844) 520-3239
• Email: ionisATTRCM2study@clinicaltrialmedia.com
• Status: Recruiting
• Phase: Phase 3
• Start date: November 30, 2022
• Completion date: August 2029