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Активно (без набиране) Фаза 3 NCT06183931

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Фаза 3 – широко изпитване преди одобрение
Заболявания: Transthyretin Amyloid Cardiomyopathy

Спонсор: Alexion Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The primary objective of this study is to access the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the total occurrences of all-cause mortality (ACM) and cardiovascular (CV) clinical events.
Кой може да участва
Inclusion Criteria: * Diagnosis of ATTR-CM with either wild-type or variant TTR genotype * End-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at Screening * NT-proBNP \> 2000 pg/mL at Screening * Treatment with a loop diuretic for at least 30 days prior to Screening * History of heart failure NYHA Class II-IV at Screening * Life expectancy of ≥ 6 months as per the Investigator's judgment * Males and females of childbearing ability must use contraception Exclusion Criteria: * Known leptomeningeal amyloidosis * Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis * Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening * Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment * LVEF \< 30% on echocardiography * Renal failure requiring dialysis or an eGFR \< 20 mL/min/1.73 m2 at Screening * Polyneuropathy with PND score IV
Места на провеждане 24
Argentina (1)
Research Site
Buenos Aires
Австралия (1)
Research Site
Bedford Park
Белгия (1)
Research Site
Bruges
Бразилия (1)
Research Site
Aracaju
Канада (1)
Research Site
Calgary , Alberta
Китай (1)
Research Site
Beijing
Чехия (1)
Research Site
Prague
Дания (1)
Research Site
Aarhus
Франция (1)
Research Site
Bron
Гърция (1)
Research Site
Athens
Ireland (1)
Research Site
Dublin
Израел (1)
Research Site
Beer Yaakov
Италия (1)
Research Site
Bologna
Япония (1)
Research Site
Bunkyō City
Нидерландия (1)
Research Site
Groningen
Норвегия (1)
Research Site
Lørenskog
Полша (1)
Research Site
Gdansk
Южна Корея (1)
Research Site
Busan
Испания (1)
Research Site
A Coruña
Швеция (1)
Research Site
Gothenburg
Taiwan (1)
Research Site
New Taipei City
Турция (1)
Research Site
Ankara
Великобритания (1)
Research Site
Birmingham
САЩ (1)
Research Site
Irvine , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
90 Years
Здрави доброволци
Не
Начална дата
11.01.2024
Крайна дата
05.10.2027
Регистрационен номер
NCT06183931
Източник
anzctr
Запитване за медицински туризъм

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