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Набира участници Фаза 3 NCT07052903

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Фаза 3 – широко изпитване преди одобрение
Заболявания: Transthyretin Amyloidosis With Cardiomyopathy

Спонсор: Alnylam Pharmaceuticals

Налично на: БГ
Обобщение
The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Кой може да участва
Inclusion Criteria * Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis. * Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic. * Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>300 ng/L and \<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \>600 ng/L and \<8500 ng/L. * Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator. Exclusion Criteria * Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3. * Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV. * Has an estimated glomerular filtration rate eGFR of \<30 mL/min/1.73m\^2 at screening. * Has received prior or currently receiving TTR-lowering therapy
Места на провеждане 29
Argentina (1)
Clinical Trial Site
Buenos Aires
Австралия (1)
Clinical Trial Site
Adelaide
Белгия (1)
Clinical Trial Site
Aalst
Бразилия (1)
Clinical Trial Site
Belo Horizonte
Канада (1)
Clinical Trial Site
London
Chile (1)
Clinical Trial Site
Santiago
Китай (1)
Clinical Trial Site
Dongcheng
Чехия (1)
Clinical Trial Site
Brno
Дания (1)
Clinical Trial Site
Aarhus N
Франция (1)
Clinical Trial Site
Chambray-lès-Tours
Гърция (1)
Clinical Trial Site
Athens
Hong Kong (1)
Clinical Trial Site
Hong Kong
Унгария (1)
Clinical Trial Site
Budapest
Израел (1)
Clinical Trial Site
Be’er Ya‘aqov
Италия (1)
Clinical Trial Site
Ancona
Япония (1)
Clinical Trial Site
Bunkyō City
Malaysia (1)
Clinical Trial Site
Kajang
Нидерландия (1)
Clinical Trial Site
Eindhoven
New Zealand (1)
Clinical Trial Site
Christchurch
Норвегия (1)
Clinical Trial Site
Ålesund
Португалия (1)
Clinical Trial Site
Carnaxide
Румъния (1)
Clinical Trial Site
Bucharest
Словакия (1)
Clinical Trial Site
Košice
Южна Корея (1)
Clinical Trial Site
Incheon
Испания (1)
Clinical Trial Site
A Coruña
Швеция (1)
Clinical Trial Site
Gothenburg
Taiwan (1)
Clinical Trial Site
New Taipei City
Великобритания (1)
Clinical Trial Site
Bellshill
САЩ (1)
Clinical Trial Site
La Jolla , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
02.07.2025
Крайна дата
30.11.2032
Регистрационен номер
NCT07052903
Източник
anzctr
Запитване за медицински туризъм

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