RecruitingNCT07654855

Long-term Safety of Eplontersen Treated aTTR Patients and in Liver Transplant and Severely Hepatic Impaired Subpopulations

Post-Authorisation Safety Study: A Cohort Event Monitoring Study to Characterise the Use of Eplontersen in Patients With Prior Liver Transplant and Pre-existing Severe Hepatic Impairment and to Assess Long-term Safety Among All New Users of Eplontersen (sTTRing)


Sponsor

AstraZeneca

Enrollment

320 participants

Start Date

Sep 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of this observational cohort study is to characterise use of eplontersen in patients with prior liver transplant or with pre-existing severe hepatic impairment, as well as to assess long-term safety among all new users of eplontersen; all are areas of missing information Primary objectives are: 1. To describe demographic and clinical characteristics of patients at eplontersen initiation, including the prevalence of prior liver transplant (overall and by reason for liver transplant), and the prevalence of severe hepatic impairment; and to describe patients in these subgroups (prior liver transplant, severe hepatic impairment). 2. To describe long-term safety in patients who initiate eplontersen treatment, including onset of new clinical events, abnormal laboratory values and serious adverse events.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying None ( observational study ) for people with transthyretin amyloidosis, transthyretin amyloidosis with cardiomyopathy, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNone ( observational study )

Not applicable this is observational study no intervention is planned.


Locations(6)

Research Site

Los Angeles, California, United States

Research Site

Vancouver, British Columbia, Canada

Research Site

Beijing, China

Research Site

Hanover, Germany

Research Site

Majadahonda, Spain

Research Site

Birmingham, United Kingdom

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NCT07654855


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