Transthyretin Amyloid Cardiomyopathy Clinical Trial
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Summary
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.
Eligibility Criteria
Inclusion Criteria:
Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria
Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF
Exclusion Criteria:
Has known primary amyloidosis or leptomeningeal amyloidosis
Has New York Heart Association (NYHA) Class IV heart failure
Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria
Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit
Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2
Has received prior TTR-lowering treatment
Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease
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There are 13 Locations for this study
Stanford California, 94305, United States
Washington District of Columbia, 20010, United States
Gainesville Georgia, 30501, United States
Evanston Illinois, 60201, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02118, United States
Rochester Minnesota, 55902, United States
Manhasset New York, 11030, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
Buenos Aires , , Argentina
Adelaide , , Australia
Melbourne , , Australia
Sydney , , Australia
Westmead , , Australia
Woolloongabba , , Australia
Vienna , , Austria
Anderlecht , , Belgium
Dendermonde , , Belgium
Ghent , , Belgium
Leuven , , Belgium
Quebec City , , Canada
Toronto , , Canada
Zagreb , , Croatia
Olomouc , , Czechia
Prague , , Czechia
Aarhus , , Denmark
Odense , , Denmark
Créteil , , France
Marseille , , France
Paris , , France
Toulouse , , France
Essen , , Germany
Göttingen , , Germany
Heidelberg , , Germany
Leipzig , , Germany
Münster , , Germany
Würzburg , , Germany
Budapest , , Hungary
Dublin , , Ireland
Haifa , , Israel
Aichi , , Japan
Fukuoka , , Japan
Kagawa , , Japan
Kashihara , , Japan
Kumamoto , , Japan
Matsumoto , , Japan
Nankoku , , Japan
Osaka , , Japan
Tokyo , , Japan
Seoul , , Korea, Republic of
Riga , , Latvia
Kaunas , , Lithuania
Groningen , , Netherlands
Utrecht , , Netherlands
Oslo , , Norway
Lima , , Peru
San Miguel , , Peru
Gdańsk , , Poland
Wrocław , , Poland
Guimarães , , Portugal
Lisboa , , Portugal
Porto , , Portugal
Barcelona , , Spain
Bilbao , , Spain
Huelva , , Spain
Madrid , , Spain
Málaga , , Spain
Gothenburg , , Sweden
Umeå , , Sweden
Birmingham , , United Kingdom
Cardiff , , United Kingdom
Glasgow , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Middlesbrough , , United Kingdom
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