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An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
EU CTIS ID: 2022-502415-11-00
What this study is testing
To evaluate the safety and tolerability of extended dosing with eplontersen in subjects with ATTR-CM.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Satisfactory completion of the Treatment Period and the End of Treatment Visit of the Index Study (ION‑682884-CS2) OR Diagnosis of ATTR-CM and satisfactory participation on ISIS 420915CS101 study, as judged by the Investigator and Sponsor
- Investigator is willing to treat the subject with open label ION-682884 (eplontersen)
- Willingness to adhere to vitamin A supplementation per protocol
You likely can't join if
- Permanently discontinued Study Drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study)
- Have any new condition or worsening of existing condition that in the opinion of the Investigator or Sponsor would make the subject unsuitable for enrollment, or which could interfere with the subject participating in or completing the study, including need for treatment with medications disallowed in the Index Study
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Brazil
- United Kingdom
- Japan
- Argentina
- Israel
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Brazil; United Kingdom; Japan; Argentina; Israel and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.