An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502415-11-00

Acronym

ION-682884-CS12

Enrollment

339

Registered

2023-05-30

Start date

2023-06-16

Completion date

Unknown

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Brief summary

Description of TEAEs (AE/SAE/AESI), Analysis of change in safety laboratory assessments of interest over time (Platelet count, eGFR, UPCR, LFTs)

Detailed description

Analysis of change in clinical and Biomarker assessment of interest and survival: •TTR serum levels •6MWT •Kansas City Cardiomyopathy Questionnaire (KCCQ) • CV-death •All-cause death

Interventions

DRUGConcavit Capsules

DRUGION 682884

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Description of TEAEs (AE/SAE/AESI), Analysis of change in safety laboratory assessments of interest over time (Platelet count, eGFR, UPCR, LFTs)	—

Secondary

Measure	Time frame
Analysis of change in clinical and Biomarker assessment of interest and survival: •TTR serum levels •6MWT •Kansas City Cardiomyopathy Questionnaire (KCCQ) • CV-death •All-cause death	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026