APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
NCT ID: NCT03997383
Last Updated: 2026-01-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2019-09-12
2027-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Patisiran
Participants will be administered multiple doses of patisiran in the double-blind and open-label extension period.
Patisiran
Patisiran will be administered by intravenous (IV) infusion.
Placebo
Participants will be administered multiple doses of placebo in the double-blind period. In the open-label extension period, participants will be administered multiple doses of patisiran.
Placebo
Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.
Patisiran
Patisiran will be administered by intravenous (IV) infusion.
Interventions
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Placebo
Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.
Patisiran
Patisiran will be administered by intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medical history of heart failure with at least 1 prior hospitalization for heart failure, or current clinical evidence (signs and symptoms of heart failure)
* Clinically stable with no cardiovascular related hospitalizations within 6 weeks of study start
* Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6 months with evidence of disease progression while on tafamidis treatment
* Able to complete ≥150 m on the 6-minute walk test
* Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of heart failure severity, \>300 ng/L and \<8500 ng/L; in participants with permanent or persistent atrial fibrillation, screening NT-proBNP\> 600 ng/L and \<8500 ng/L
Exclusion Criteria
* Received prior TTR lowering treatment
* New York Heart Association heart failure classification of III and at high risk
* New York Heart Association heart failure classification of IV
* Neuropathy requiring cane or stick to walk, or is wheelchair bound
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
* Abnormal liver function
* Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* Has non-amyloid disease that significantly affects ability to walk (e.g., severe chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular disease affecting ambulation)
* Prior or planned heart, liver, or other organ transplant
* Other cardiomyopathy not related to ATTR amyloidosis
18 Years
85 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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Los Angeles, California, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Iowa City, Iowa, 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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Burlington, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, 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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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Norfolk, Virginia, United States
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Buenos Aires, Buenos Aires, Argentina
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San Juan Bautista, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Westmead, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Box Hill, Victoria, Australia
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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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Porto Alegre, Rio Grande do Sul, 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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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Sofia, Sofia-Grad, Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Santiago, , Chile
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Prague, Praha, Hlavní Mesto, Czechia
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aarhus N, Aarhus, Denmark
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Copenhagen, , Denmark
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Odense C, , Denmark
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Clichy, Paris, France
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Créteil, Val-de-Marne, France
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Rennes, , France
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Toulouse, , France
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Lai Chi Kok, , Hong Kong
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Bologna, Emilia-Romagna, Italy
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Messina, Sicily, Italy
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Florence, , Italy
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Pavia, , Italy
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Nagoya, Aichi-ken, Japan
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Kurume, Fukuoka, Japan
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Matsumoto, Nagano, Japan
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Suita, Osaka, Japan
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Bunkyo-ku, Tokyo, Japan
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Fukuoka, , Japan
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Kumamoto, , Japan
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Mexico City, , Mexico
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Christchurch, , New Zealand
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Hamilton, , New Zealand
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Lódz, Lódzkie, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Porto, , Portugal
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Senhora da Hora, , Portugal
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Viseu, , Portugal
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Seoul, , South Korea
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Stockholm, , Sweden
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Taipei, , Taiwan
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Bellshill, Lanarkshire, United Kingdom
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London, London, City of, United Kingdom
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Hexham, Northumberland, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Cardiff, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Mesquita CT, Schwartzmann P, Correia EB, Simoes MV, Biolo A, Duque DR, Jay PY, Fernandes F. Patisiran Treatment in the Brazilian Subpopulation of the Phase 3 APOLLO-B Study in Transthyretin Amyloidosis with Cardiomyopathy: Post Hoc Analysis. Arq Bras Cardiol. 2025 Mar;122(4):e20240568. doi: 10.36660/abc.20240568. English, Portuguese.
Maurer MS, Kale P, Fontana M, Berk JL, Grogan M, Gustafsson F, Hung RR, Gottlieb RL, Damy T, Gonzalez-Duarte A, Sarswat N, Sekijima Y, Tahara N, Taylor MS, Kubanek M, Donal E, Palecek T, Tsujita K, Tang WHW, Yu WC, Obici L, Simoes M, Fernandes F, Poulsen SH, Diemberger I, Perfetto F, Solomon SD, Di Carli M, Badri P, White MT, Chen J, Yureneva E, Sweetser MT, Jay PY, Garg PP, Vest J, Gillmore JD; APOLLO-B Trial Investigators. Patisiran Treatment in Patients with Transthyretin Cardiac Amyloidosis. N Engl J Med. 2023 Oct 26;389(17):1553-1565. doi: 10.1056/NEJMoa2300757.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001458-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-TTR02-011
Identifier Type: -
Identifier Source: org_study_id
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