Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
NCT ID: NCT02791230
Last Updated: 2025-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1733 participants
INTERVENTIONAL
2016-06-13
2023-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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Tafamidis
Active treatment - 61 mg or if not available, tafamidis meglumine 80 mg
Tafamidis
Soft gel capsules administered once a day for 60 months
Interventions
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Tafamidis
Soft gel capsules administered once a day for 60 months
Eligibility Criteria
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Inclusion Criteria
Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
Cardiovascular Clinical Trials Unit (CCTU)
Birmingham, Alabama, United States
University Hospital, University of Alabama at Birmingham
Birmingham, Alabama, United States
California Heart Center
Beverly Hills, California, United States
Cedars-Sinai Medical Care Foundation
Beverly Hills, California, United States
Altman Clinical Translational Research Institute
La Jolla, California, United States
University of California, San Diego
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Diego Medical Center - Hillcrest
San Diego, California, United States
Center Adv Lab Medicine
San Diego, California, United States
UCSF Ambulatory Care Center
San Francisco, California, United States
University of California
San Francisco, California, United States
UCSF Cardiovascular Care and Prevention Center
San Francisco, California, United States
Stanford University Hospital and Clinics
Stanford, California, United States
Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Northwestern Medical Group
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Medical Center Investigational Pharmacy
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Michigan Medicine,University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Hospital-Rochester
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
NYU Langone Health
New York, New York, United States
Center for Advanced Cardiac Care
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
OHSU Research Pharmacy Services
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Vanderbilt Univ. Med. Ctr
Nashville, Tennessee, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
University of Utah, Division of Cardiovascular Medicine
Salt Lake City, Utah, United States
Instituto Cardiovascular de Buenos Aires
Buenos Aires, , Argentina
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Eastern Health (Box Hill Hospital)
Box Hill, Victoria, Australia
UZ Leuven
Leuven, , Belgium
Hospital Universitário Clementino Fraga Filho (UFRJ)
Rio de Janeiro, Rio de Janeiro, Brazil
University of Calgary/Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Institut klinicke a experimentalni mediciny
Prague, , Czechia
Hopital de La Timone
Marseille, CAN, France
CHU Henri Mondor
Créteil, , France
Hôpital De La Timone
Marseille, , France
Hopital Bichat
Paris, , France
CHU de Rennes - Hopital Pontchaillou
Rennes, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
Medical University of Heidelberg
Heidelberg, , Germany
Universitätsklinikum Münster
Münster, , Germany
Clinical Trial Pharmacy
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Shinshu University Hospital
Nagano, , Japan
University Medical Center Groningen
Groningen, , Netherlands
Unidad de Insuficiencia Cardiaca Avanzada y Transplante Cardiaco
A Coruña, LA Coruna, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Skellefteå Lasarett
Skellefteå, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Investigational Drug Services
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Barts Health NHS Trust, St Bartholomew's Hospital
London, , United Kingdom
Countries
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References
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Crespo-Leiro MG, Hanna M, Damy T, Delgado D, Ebede B, Marino V, Wang R, Maurer MS, Garcia-Pavia P, Drachman BM. Early Access to Tafamidis for Patients With Transthyretin Amyloid Cardiomyopathy. JACC Adv. 2025 Sep 10;4(10 Pt 2):102122. doi: 10.1016/j.jacadv.2025.102122. Online ahead of print.
Damy T, Wang R, Maurer MS, Gillmore JD, Fontana M. Long-term efficacy of tafamidis in patients with transthyretin amyloid cardiomyopathy by National Amyloidosis Centre stage. Eur J Heart Fail. 2025 Jun 9. doi: 10.1002/ejhf.3696. Online ahead of print.
Drachman B, Damy T, Hanna M, Wang R, Angeli FS, Garcia-Pavia P. Long-term tafamidis efficacy in patients with transthyretin amyloid cardiomyopathy by baseline left ventricular ejection fraction. Eur J Heart Fail. 2024 Sep;26(9):2038-2046. doi: 10.1002/ejhf.3330. Epub 2024 Jun 26.
Garcia-Pavia P, Sultan MB, Gundapaneni B, Sekijima Y, Perfetto F, Hanna M, Witteles R. Tafamidis Efficacy Among Octogenarian Patients in the Phase 3 ATTR-ACT and Ongoing Long-Term Extension Study. JACC Heart Fail. 2024 Jan;12(1):150-160. doi: 10.1016/j.jchf.2023.08.032. Epub 2023 Nov 8.
Elliott P, Gundapaneni B, Sultan MB, Ines M, Garcia-Pavia P. Improved long-term survival with tafamidis treatment in patients with transthyretin amyloid cardiomyopathy and severe heart failure symptoms. Eur J Heart Fail. 2023 Nov;25(11):2060-2064. doi: 10.1002/ejhf.2974. Epub 2023 Jul 26.
Elliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-term survival in people with transthyretin amyloid cardiomyopathy who took tafamidis: A Plain Language Summary. Future Cardiol. 2023 Jan;19(1):7-17. doi: 10.2217/fca-2022-0096. Epub 2023 Jan 30.
Elliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy. Circ Heart Fail. 2022 Jan;15(1):e008193. doi: 10.1161/CIRCHEARTFAILURE.120.008193. Epub 2021 Dec 20.
Damy T, Garcia-Pavia P, Hanna M, Judge DP, Merlini G, Gundapaneni B, Patterson TA, Riley S, Schwartz JH, Sultan MB, Witteles R. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021 Feb;23(2):277-285. doi: 10.1002/ejhf.2027. Epub 2020 Nov 12.
Li B, Alvir J, Stewart M. Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial. Cardiol Ther. 2020 Dec;9(2):535-540. doi: 10.1007/s40119-020-00179-2. Epub 2020 Jun 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2016-000868-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B3461045
Identifier Type: -
Identifier Source: org_study_id
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