NCT04153149Active, not recruitingPhase 3
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 655 (actual)
- First submitted
- 4 Nov 2019
- Start date
- 26 Nov 2019
- Primary completion date
- 8 May 2024
- Lead sponsor
- Alnylam Pharmaceuticals
- Diseases
- Amyloidosis
- NCT number
- NCT04153149
- EU CT number
- 2023-508366-15-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 655
- From 26 Nov 2019 to the primary completion date, 8 May 2024
- 107 sites in 33 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received prior TTR-lowering treatment
Other illness
- 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 other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease
Lab values
- Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2
Other
- Has known primary amyloidosis or leptomeningeal amyloidosis
- Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (107)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trial Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Northmead | Australia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Dendermonde | Belgium | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Bogotá D.C. | Colombia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Bellshill | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Hexham | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Londonderry | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Nankoku | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Shinjuku-Ku | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Tsurumai-cho | Japan | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Hamra | Lebanon | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Kaunas | Lithuania | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Callao - Vellavista | Peru | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Lima - San Miguel | Peru | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | San Isidro | Peru | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Cracow | Poland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Faro | Portugal | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Guimarães | Portugal | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Mecca | Saudi Arabia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Clinical Trial Site Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.