A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
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- STATUS
- Recruiting
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- End date
- Jul 8, 2024
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- participants needed
- 140
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- sponsor
- Ionis Pharmaceuticals, Inc.
Summary
The purpose of this study is to evaluate the safety and tolerability of extended dosing with Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).
Description
This is a multicenter, open-label, Phase 3 study in up to approximately 140 participants. Eligible participants will receive Eplontersen once every 4 weeks for up to 157 weeks. 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 (≤) 8-week screening period, a 157 weeks treatment period, and a 24-week post-treatment evaluation period.
Details
| Condition | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy |
|---|---|
| Treatment | Eplontersen, ION-682884 |
| Clinical Study Identifier | NCT05071300 |
| Sponsor | Ionis Pharmaceuticals, Inc. |
| Last Modified on | 8 April 2023 |
Eligibility
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