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.

View Eligibility Criteria

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

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

655

Study ID:

NCT04153149

Recruitment Status:

Active, not recruiting

Sponsor:

Alnylam Pharmaceuticals

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There are 13 Locations for this study

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Clinical Trial Site
Stanford California, 94305, United States
Clinical Trial Site
Washington District of Columbia, 20010, United States
Clinical Trial Site
Gainesville Georgia, 30501, United States
Clinical Trial Site
Evanston Illinois, 60201, United States
Clinical Trial Site
Boston Massachusetts, 02115, United States
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Boston Massachusetts, 02118, United States
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Rochester Minnesota, 55902, United States
Clinical Trial Site
Manhasset New York, 11030, United States
Clinical Trial Site
New York New York, 10032, United States
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Durham North Carolina, 27710, United States
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Cleveland Ohio, 44195, United States
Clinical Trial Site
Philadelphia Pennsylvania, 19104, United States
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Houston Texas, 77030, United States
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Buenos Aires , , Argentina
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Adelaide , , Australia
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Melbourne , , Australia
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Sydney , , Australia
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Westmead , , Australia
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Woolloongabba , , Australia
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Vienna , , Austria
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Anderlecht , , Belgium
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Dendermonde , , Belgium
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Ghent , , Belgium
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Leuven , , Belgium
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Quebec City , , Canada
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Toronto , , Canada
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Zagreb , , Croatia
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Olomouc , , Czechia
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Prague , , Czechia
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Aarhus , , Denmark
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Odense , , Denmark
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Créteil , , France
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Marseille , , France
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Paris , , France
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Toulouse , , France
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Essen , , Germany
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Göttingen , , Germany
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Heidelberg , , Germany
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Leipzig , , Germany
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Münster , , Germany
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Würzburg , , Germany
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Budapest , , Hungary
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Dublin , , Ireland
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Haifa , , Israel
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Aichi , , Japan
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Fukuoka , , Japan
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Kagawa , , Japan
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Kashihara , , Japan
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Kumamoto , , Japan
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Matsumoto , , Japan
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Nankoku , , Japan
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Osaka , , Japan
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Tokyo , , Japan
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Seoul , , Korea, Republic of
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Riga , , Latvia
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Kaunas , , Lithuania
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Groningen , , Netherlands
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Utrecht , , Netherlands
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Oslo , , Norway
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Lima , , Peru
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San Miguel , , Peru
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Gdańsk , , Poland
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Wrocław , , Poland
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Guimarães , , Portugal
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Lisboa , , Portugal
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Porto , , Portugal
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Barcelona , , Spain
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Bilbao , , Spain
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Huelva , , Spain
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Madrid , , Spain
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Málaga , , Spain
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Gothenburg , , Sweden
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Umeå , , Sweden
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Birmingham , , United Kingdom
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Cardiff , , United Kingdom
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Glasgow , , United Kingdom
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London , , United Kingdom
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Manchester , , United Kingdom
Clinical Trial Site
Middlesbrough , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

655

Study ID:

NCT04153149

Recruitment Status:

Active, not recruiting

Sponsor:


Alnylam Pharmaceuticals

How clear is this clinincal trial information?

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