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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)

NCT05667493

Enrolling By InvitationPhase 3

Sponsor: Ionis Pharmaceuticals, Inc.

Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Interventions: Eplontersen

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. 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.
2. Investigator is willing to treat the participant with open-label eplontersen.
3. Willingness to adhere to vitamin A supplementation per protocol.

Exclusion Criteria:

1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
2. 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.
Locations (134)
  • Scottsdale, Arizona, United States
  • Beverly Hills, California, United States
  • La Jolla, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Washington D.C., District of Columbia, United States
  • Weston, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Fayetteville, Georgia, United States
  • Chicago, Illinois, United States
  • Maywood, Illinois, United States
  • Indianapolis, Indiana, United States
  • Kansas City, Kansas, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Rochester, Minnesota, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • + 104 more on CT.gov