An Extension Study to Assess Long-Term Safety of Eplontersen in Adults 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)
ClinicalTrials.gov ID: NCT05667493
Sponsor: Ionis Pharmaceuticals, Inc.
Information provided by: Ionis Pharmaceuticals, Inc. (Responsible Party)
Last Update Posted: 2023-05-25
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
Detailed 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.
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)
Intervention / Treatment:
- Drug: Eplontersen
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-11-30 |
| Primary Completion (Estimated) | 2029-04 |
| Study Completion (Estimated) | 2029-08 |
| Enrollment (Estimated) | 1400 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
ION-682884-CS12 |