Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

PHASE3CompletedINTERVENTIONAL
Enrollment

1,733

Participants

Timeline

Start Date

June 13, 2016

Primary Completion Date

October 26, 2023

Study Completion Date

November 2, 2023

Conditions
Transthyretin (TTR) Amyloid Cardiomyopathy
Interventions
DRUG

Tafamidis

Soft gel capsules administered once a day for 60 months

Trial Locations (80)

100

Investigational Drug Services, Taipei

National Taiwan University Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

2145

Westmead Hospital, Westmead

3000

UZ Leuven, Leuven

3128

Eastern Health (Box Hill Hospital), Box Hill

4102

Princess Alexandra Hospital, Woolloongabba

10016

NYU Langone Health, New York

10032

Center for Advanced Cardiac Care, New York

Columbia University Irving Medical Center, New York

13005

Hopital de La Timone, Marseille

13385

Hôpital De La Timone, Marseille

15006

Unidad de Insuficiencia Cardiaca Avanzada y Transplante Cardiaco, A Coruña

19104

Penn Presbyterian Medical Center, Philadelphia

21201

University of Maryland, Baltimore, Baltimore

21287

Johns Hopkins University, Baltimore

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27710

Duke University, Durham

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

31059

CHU de Toulouse - Hôpital Rangueil, Toulouse

33136

Sylvester at Deerfield Beach, Deerfield Beach

University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center, Miami

35033

CHU de Rennes - Hopital Pontchaillou, Rennes

CHU de Rennes - Hôpital Pontchaillou, Rennes

35233

The Kirklin Clinic of UAB Hospital, Birmingham

35294

Cardiovascular Clinical Trials Unit (CCTU), Birmingham

University Hospital, University of Alabama at Birmingham, Birmingham

37232

Vanderbilt Univ. Med. Ctr, Nashville

40138

Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi, Bologna

44195

Cleveland Clinic, Cleveland

48109

Michigan Medicine,University of Michigan, Ann Arbor

48149

Universitätsklinikum Münster, Münster

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

55902

Mayo Clinic Hospital-Rochester, Rochester

55905

Mayo Clinic, Rochester

60453

Advocate Christ Medical Center, Oak Lawn

60611

Northwestern Medical Group, Chicago

Northwestern Memorial Hospital, Chicago

69120

Medical University of Heidelberg, Heidelberg

75018

Hopital Bichat, Paris

84112

Huntsman Cancer Hospital, Salt Lake City

84132

University of Utah Hospitals & Clinics, Salt Lake City

University of Utah, Division of Cardiovascular Medicine, Salt Lake City

90048

Cedars-Sinai Medical Center, Los Angeles

90211

California Heart Center, Beverly Hills

Cedars-Sinai Medical Care Foundation, Beverly Hills

92037

Altman Clinical Translational Research Institute, La Jolla

University of California, San Diego, La Jolla

92103

University of California, San Diego Medical Center - Hillcrest, San Diego

92121

Center Adv Lab Medicine, San Diego

94010

CHU Henri Mondor, Créteil

94143

UCSF Ambulatory Care Center, San Francisco

University of California, San Francisco

94158

UCSF Cardiovascular Care and Prevention Center, San Francisco

94305

Stanford University Hospital and Clinics, Stanford

97239

OHSU Center for Health and Healing, Portland

OHSU Research Pharmacy Services, Portland

Oregon Health & Science University, Portland

02118

Boston Medical Center Investigational Pharmacy, Boston

Boston Medical Center, Boston

Boston University Medical Center, Boston

07112

Newark Beth Israel Medical Center, Newark

C1428ART

Instituto Cardiovascular de Buenos Aires, Buenos Aires

21941-913

Hospital Universitário Clementino Fraga Filho (UFRJ), Rio de Janeiro

T2N 4Z6

University of Calgary/Foothills Medical Centre, Calgary

V5Z 1M9

Vancouver General Hospital, Vancouver

M5G 2C4

Toronto General Hospital, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

128 08

Vseobecna fakultni nemocnice v Praze, Prague

140 21

Institut klinicke a experimentalni mediciny, Prague

Unknown

Clinical Trial Pharmacy, Hong Kong

Queen Mary Hospital, Hong Kong

830-0011

Kurume University Hospital, Kurume-shi

860-8556

Kumamoto University Hospital, Kumamoto

390-8621

Shinshu University Hospital, Nagano

9713 GZ

University Medical Center Groningen, Groningen

931 86

Skellefteå Lasarett, Skellefteå

751 85

Akademiska Sjukhuset, Uppsala

EC1A 7BE

Barts Health NHS Trust, St Bartholomew's Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02791230 - Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy | Biotech Hunter | Biotech Hunter