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NCT07654855Recruiting

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)

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
320 (estimated)
First submitted
19 May 2026
Start date
1 Sept 2026
Primary completion date
29 Jan 2032
Lead sponsor
AstraZeneca
Diseases
Amyloidosis
NCT number
NCT07654855

What you commit to

  • Study type: Observational
  • Planned participants: 320
  • From 1 Sept 2026 to the primary completion date, 29 Jan 2032
  • 6 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
VancouverCanadaRecruiting
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Coordinator of this site? Confirm its status
BeijingChinaRecruiting
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Coordinator of this site? Confirm its status
HanoverGermanyRecruiting
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Coordinator of this site? Confirm its status
MajadahondaSpainRecruiting
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Coordinator of this site? Confirm its status
BirminghamUnited KingdomRecruiting
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Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.