Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

PHASE3CompletedINTERVENTIONAL
Enrollment

632

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

May 11, 2023

Study Completion Date

May 11, 2023

Conditions
AmyloidosisAmyloid CardiomyopathyTransthyretin AmyloidosisCardiomyopathiesHeart Diseases
Interventions
DRUG

acoramidis

TTR stabilizer administered orally twice daily (BID)

DRUG

Placebo Oral Tablet

Non-active control administered orally twice daily (BID)

Trial Locations (104)

1640

Middlemore Hospital, Otahuhu

2010

Saint Vincent's Hospital Sydney, Sydney

3240

Waikato Hospital, Hamilton

8200

Aarhus Universitetshospital, Aarhus

10010

New York University Langone Health, New York

10029

Mount Sinai Hospital, New York

10034

Columbia University Medical Center, New York

10461

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital, Manhasset

11422

Laurelton Heart Specialist, Rosedale

13620

Seoul National University Bundang Hospital, Seongnam-si

Seoul National University Hospital, Seoul

15212

Allegheny General Hospital, Pittsburgh

15213

University of Pittsburgh, Pittsburgh

19104

Penn Presbyterian Medical Center, Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

21005

Hospital Juan Ramón Jiménez, Huelva

21218

MedStar Medical Group Cardiology at Franklin Square Medical Center, Baltimore

23298

Virginia Commonwealth University Medical Center, Richmond

24014

Carilion Clinic Roanoke Heart Institute, Roanoke

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27514

University of North Carolina - Chapel Hill, Chapel Hill

27710

Duke University Health System, Durham

29425

The Medical University of South Carolina, Charleston

29605

Prisma Health - Greenville Memorial Hospital, Greenville

30322

Emory Heart and Vascular Center, Atlanta

30606

Piedmont Heart Institute Athens, Athens

33136

University of Miami - Sylvester Comprehensive Cancer Center, Miami

44195

Cleveland Clinic, Cleveland

46202

Indiana University, Indianapolis

55905

Mayo Clinic, Rochester

60201

NorthShore University Health System, Evanston

60611

Northwestern University, Chicago

60637

The University of Chicago Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

64111

Saint Luke's Hospital - Kansas City, Kansas City

75390

University of Texas Southwestern Medical Center, Dallas

80045

University of Colorado Hospital - Anschutz Medical Campus, Aurora

84132

University of Utah, Salt Lake City

90048

Cedars-Sinai Medical Center, Los Angeles

90404

Pacific Heart Institute, Santa Monica

97239

Oregon Health and Science University, Portland

98195

University of Washington School of Medicine, Seattle

99204

Providence Sacred Heart Medical Center, Spokane

06473

Yale School of Medicine, New Haven

02118

Boston University School of Medicine, Boston

02135

Saint Elizabeth's Medical Center, Boston

07112

Newark Beth Israel Medical Center, Newark

Unknown

Royal Adelaide Hospital, Adelaide

Box Hill Hospital, Box Hill

Royal Hobart Hospital, Hobart

Fiona Stanley Hospital, Murdoch

Princess Alexandra Hospital, Woolloongabba

Ziekenhuis Oost-Limburg - Campus Sint-Jan, Genk

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende, Bruges

Onze-Lieve-Vrouw Ziekenhuis Aalst, Aalst

Universitair Ziekenhuis Leuven, Leuven

Hospital Cárdio Pulmonar, Salvador

INCOR, São Paulo

Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre

CancerCare Manitoba - St. Boniface, Winnipeg

Montreal Heart Institute, Montreal

St. Anne´s University Hospital, Brno střed

General University Hospital in Prague, New Town

Institute for Clinical and Experimental Medicine, Prague

Alexandra General Hospital of Athens, Athens

Mater Misericordiae University Hospital, Dublin

Saint Vincents University Hospital, Dublin

Hadassah University Hospital Ein Kerem, Jerusalem

The Chaim Sheba Medical Center, Tel Litwinsky

Ospedale San Donato, Arezzo

Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna

Azienda Ospedaliero - Universitaria Careggi, Florence

Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica, Pisa

Ospedale degli Infermi, Rimini

Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma, Roma

Universitair Medisch Centrum Groningen, Groningen

Universitair Medisch Centrum Utrecht, Utrecht

National Institute of Cardiology, Warsaw

Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria, Lisbon

Clínica Universidad de Navarra, Pamplona

Hospital Universitari Germans Trias i Pujol, Barcelona

Hospital Juan Ramón Jiménez, Huelva

Clinica Universidad de Navarra Madrid, Madrid

Hospital Universitario Puerta de Hierro, Madrid

Hospital Son Llàtzer, Palma de Mallorca

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

Hospital Clínico Universitario de Valencia, Valencia

90020-090

Santa Casa de Misericordia - Porto Alegre, Porto Alegre

14026-900

CAPED - Centro Avançado de Pesquisa e Estudos para o Diagnóstico, Ribeirão Preto

T2N 4Z6

University of Calgary, Calgary

V5Z 1M9

University of British Columbia, Vancouver

B3H 3A7

Halifax Infirmary, Halifax

M4P 1E4

Toronto Heart Centre, Toronto

M5G 2N2

University of Toronto, Toronto

H2X 3H8

Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame, Montreal

H4J 1C5

Hôpital du Sacré-Coeur de Montréal, Montreal

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec

G5L 5T1

Hôpital régional de Rimouski, Rimouski

6229 HX

Maastricht Universitair Medisch Centrum, Maastricht

4099-001

Centro Hospitalar do Porto, Porto

NW3 2PF

Royal Free Hospital, London

SE1 1YR

Richmond Pharmacology, London

All Listed Sponsors
lead

Eidos Therapeutics, a BridgeBio company

INDUSTRY

NCT03860935 - Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy | Biotech Hunter | Biotech Hunter