An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Phase 1

Recruiting

• Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM); MedDRA version: 20.0Level: LLTClassification code: 10002020Term: Amyloid cardiomyopathy Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-502415-11-00
• Lead Sponsor: Ionis Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1246

Inclusion Criteria

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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified