Long-term safety of eplontersen in people with transthyretin amyloidosis, including after liver transplant
Follows adults with transthyretin amyloidosis who start eplontersen, to track long-term safety.
Key facts
- Who runs it
- AstraZeneca
- Where
- Hanover, GermanySee the siteAlso in 5 other countries, 5 sites
- Trial code
- Registry title
- Long-term Safety of Eplontersen Treated aTTR Patients and in Liver Transplant and Severely Hepatic Impaired Subpopulations
- Status
- Recruiting
- People taking part
- 320 people, planned
- Started
- 1 Sept 2026
- Expected to end
- 29 Jan 2032
- Type of study
- Observational
- Treatments tested
- None ( observational study )
- Record updated
- 14 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who took part in the D8450R00003 study, agreed to future research use of their data, and started eplontersen up to 1 year before joining that study.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Any ATTR phenotype or genotype. Includes people with a prior liver transplant or severe liver impairment.
- Earlier treatment
- Must have started eplontersen up to 1-year before joining D8450R00003. For comparison, people who did not take eplontersen but started another ATTR treatment can join. Must not have taken part in an interventional ATTR study in the 12-months before.
Main reasons for not taking part
- Started eplontersen more than 1-year before joining the D8450R00003 study
- Took part in an interventional ATTR study in the 12-months before joining D8450R00003
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- D8450R00003 participants who consented to have their data used for future related research studies
- D8450R00003 participants who initiated eplontersen treatment up to 1-year prior to enrolment into D8450R00003 study observation period, irrespective of ATTR phenotype or genotype. For the comparative analyses, patients unexposed to eplontersen treatment and who initiated another ATTR treatment during D8450R00003 study observation period will be included
Who cannot take part
- Patients with exposure to eplontersen more than 1-year prior to enrolment into D8450R00003 study
- Patients who participated in an interventional ATTR study in the 12-months prior to enrolment into D8450R00003 study
Where in Germany
Also in 5 other countries, 5 sites
- HanoverHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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
Read full original descriptionShow less
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.
The group in the trial
- Eplontersen users
D8450R00003 population of new and prior eplontersen users (including prior liver transplant and severe hepatic impairment subpopulations)
Treatment: None ( observational study )
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Long-term safety of eplontersen in people with transthyretin amyloidosis, including after liver transplantGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 14 September 2026