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

Recruitingn/aAges 18 Years - anyAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. D8450R00003 participants who consented to have their data used for future related research studies. 2. 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 Exclusion Criteria: 1. Patients with exposure to eplontersen more than 1-year prior to enrolment into D8450R00003 study. 2. Patients who participated in an interventional ATTR study in the 12-months prior to enrolment into D8450R00003 study.
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What it tests

  • None ( observational study )
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Where

6 sites
Research Site
Los Angeles, United States
Research Site
Vancouver, Canada
Research Site
Beijing, China
Research Site
Hanover, Germany
Research Site
Majadahonda, Spain
Research Site
Birmingham, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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