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ACT-EARLY OLE - Clinical Trial

¿Cuál es el Propósito de este estudio?

People in the study will have visits every 6 months for up to 5 years. At these visits, doctors will take blood and urine samples. At some visits, they will do a heart test called an echocardiogram and ask questions about how the person feels and their quality of life. At each visit, participants will get a medicine called Acoramidis to take two times every day.

¿Cuál es la Condición que se está estudiando?

Newly diagnosed Cardiac Amyloidosis

¿Quién puede participar en el Estudio?

To join this study, you must have finished the ACT-EARLY study in the last 60 days and have a heart problem called ATTR-CM. You cannot join if you already have a nerve problem called ATTR-PN, if you have a different type of amyloid disease, or if you have very serious kidney disease (stage IV or V).

Grupo etario
Adultos

¿Qué Implica?

This study is testing a medicine called Acoramidis to see if it helps people with a heart problem called ATTR-CM. Some people also have another problem called ATTR-PN, which affects the nerves. The study will include people who were in an earlier study and were recently told they have ATTR-CM or both ATTR-CM and ATTR-PN. If someone has both problems, they can join this study for their heart, and their nerve problem will be treated by their doctor outside the study. If someone gets ATTR-PN later, they can stay in the study for their heart and still get care for their nerves outside the study.

Detalles del Estudio

Título Completo
A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy
Investigador Principal
Michel G. Khouri, MD
Especialista en cardiología
Número de Protocolo
IRB: PRO00118595
NCT: NCT07116473
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
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Contribuya a Duke Health