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

Conditions

• Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Eplontersen — DRUG
  Eplontersen will be administered by SC injection.

Study Details

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

Key Dates

Start date

Nov 30, 2022

Status verified

Apr 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

1,400 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Eplontersen
  Eplontersen will be administered once every month by sub-cutaneous (SC) injection for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first.

Primary Outcome Measure

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Baseline up to 36 months ]

Locations (46)

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