New study tracks safety of eplontersen in patients with liver transplants
NCT ID NCT07654855
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This observational study monitors the long-term safety of eplontersen, a treatment for transthyretin amyloidosis, in patients who have had a liver transplant or have severe liver impairment. Researchers will track side effects, lab changes, and serious health events in about 320 participants. The goal is to fill gaps in knowledge about how eplontersen affects these specific groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could provide crucial safety data on eplontersen for patients with liver issues, potentially expanding treatment options for transthyretin amyloidosis.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be limited by small sample sizes or incomplete data.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The D8450R00003 study cohort includes individuals with confirmed diagnosis of ATTR, aged ≥18 years at the time of providing the informed consent. The sTTRing study population will be a subset of the D8450R00003 cohort who meet the additional criteria below.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGLos Angeles, California, 90095, United States
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Research Site
RECRUITINGVancouver, British Columbia, V6Z 1Y6, Canada
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Research Site
RECRUITINGBeijing, China
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Research Site
RECRUITINGHanover, Germany
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Research Site
RECRUITINGMajadahonda, Spain
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Research Site
RECRUITINGBirmingham, United Kingdom
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