A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
NCT ID: NCT06679946
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
700 participants
INTERVENTIONAL
2024-12-03
2028-05-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vutrisiran 25 mg
Participants will receive vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M).
Vutrisiran
Vutrisiran administered SC q3M
Interventions
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Vutrisiran
Vutrisiran administered SC q3M
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Future or current participation in another investigational device or drug study, scheduled to occur during this study
* Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
18 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Beverly Hills, California, United States
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La Jolla, California, United States
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Stanford, California, United States
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Washington D.C., District of Columbia, United States
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Chicago, Illinois, United States
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Glenview, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Rosario, S, Argentina
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Rosario, S, Argentina
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Rosario, S, Argentina
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Córdoba, X, Argentina
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Vienna, , Austria
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Liège, LIE, Belgium
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Hasselt, LIM, Belgium
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Aalst, OVL, Belgium
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Roeselare, WVL, Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aarhus N, , Denmark
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København Ø, , Denmark
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Odense C, , Denmark
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Créteil, Val-de-Marne, France
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Marseille, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Bologna, Emilia-Romagna, Italy
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Florence, , Italy
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Pavia, , Italy
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Maastricht, LI, Netherlands
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Groningen, , Netherlands
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Utrecht, , Netherlands
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Oslo, , Norway
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Creixomil, , Portugal
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Lisbon, , Portugal
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Viseu, , Portugal
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Barcelona, B, Spain
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L'Hospitalet de Llobregat, B, Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Solna, , Sweden
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Umeå, , Sweden
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Taipei, , Taiwan
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Birmingham, BIR, United Kingdom
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London, LND, United Kingdom
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Hexham, NBL, United Kingdom
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Bellshill, , United Kingdom
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Cardiff, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Fontana M, Berk JL, Gillmore JD, Witteles RM, Grogan M, Drachman B, Damy T, Garcia-Pavia P, Taubel J, Solomon SD, Sheikh FH, Tahara N, Gonzalez-Costello J, Tsujita K, Morbach C, Pozsonyi Z, Petrie MC, Delgado D, Van der Meer P, Jabbour A, Bondue A, Kim D, Azevedo O, Hvitfeldt Poulsen S, Yilmaz A, Jankowska EA, Algalarrondo V, Slugg A, Garg PP, Boyle KL, Yureneva E, Silliman N, Yang L, Chen J, Eraly SA, Vest J, Maurer MS; HELIOS-B Trial Investigators. Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy. N Engl J Med. 2025 Jan 2;392(1):33-44. doi: 10.1056/NEJMoa2409134. Epub 2024 Aug 30.
Related Links
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ALN-TTR02-011 ClinicalTrials.gov posting
ALN-TTR02-014 ClinicalTrials.gov posting
ALN-TTRSC02-003 ClinicalTrials.gov posting
Other Identifiers
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2024-516568-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-TTRSC02-007
Identifier Type: -
Identifier Source: org_study_id