CARDIO-TTRansform OLE | Clinical Research Studies Listing

Enrolling By Invitation

99 years and younger

All

Phase N/A

2 participants needed

1 Location

Brief description of study

This is a multicenter, open-label extension of the ION-682884-CS2 Study (CARDIO-TTRansform) and of the ISIS 420915-CS101 Study. 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.

Detailed description of study

This extension 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy
Age: - 99 Years
Gender: All

Inclusion Criteria:

Satisfactory completion of 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 420915- CS101 study as judged by the Investigator and Sponsor.
Investigator is willing to treat the participant with open-label eplontersen.
Willingness to adhere to vitamin A supplementation per protocol.

Exclusion Criteria:

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 an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.

Updated on 09 Oct 2024. Study ID: 856256

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