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ACTIVE NOT RECRUITING

NCT04988386

PHASE3

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Sponsor: Eidos Therapeutics, a BridgeBio company

View on ClinicalTrials.gov

Summary

Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Official title: An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

389

Start Date

2021-10-27

Completion Date

2028-05-15

Last Updated

2025-10-14

Healthy Volunteers

Conditions

Amyloid Cardiomyopathy, Transthyretin-Related

Interventions

DRUG

Acoramidis (AG10)

Acoramidis (AG10) twice daily

Inclusion Criteria: 1. Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures. 2. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 3. Female participants of childbearing potential who engage in heterosexual intercourse must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis. Female participants using oral contraceptives must agree to use an additional birth control method. While not considered highly effective, a double-barrier method is acceptable. A male participant who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control. Exclusion Criteria: 1. Acute myocardial infarction, acute coronary syndrome or coronary revascularization within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days prior to Day 1. 2. Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study. 3. Has had a heart and/or liver transplant or is on the heart transplantation list within the year prior to Day 1 4. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for implantation of a CMAD 5. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301. 6. Has estimated glomerular filtration rate (eGFR) by modification of diet for renal disease (MDRD) formula \< 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any subsequent central lab value prior to Day 1. 7. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients. 8. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the study), participant is on prohibited medication. 9. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day 1 visit and at each study visit are required for female participants of childbearing potential. 10. In the judgment of the Investigator or Medical Monitor, has any clinically important ongoing medical condition or laboratory abnormality or condition that might jeopardize the participant's safety, increase their risk from participation, or interfere with the study. 11. Participation in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing. Participation in observational and/or registry studies should be discussed with the Medical Monitor. 12. Has any condition that in the opinion of the Investigator or Medical Monitor would preclude compliance with the study protocol such as a history of substance abuse, alcoholism, or a psychiatric condition.

Locations (72)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Colorado Hospital - Anschutz Medical Campus

Aurora, Colorado, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

NorthShore University Health System

Evanston, Illinois, United States

MedStar Medical Group Cardiology at Franklin Square

Baltimore, Maryland, United States

Boston University Medical Center General Clinical Research Unit

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

New York University Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Laurelton Heart Specialists

Rosedale, New York, United States

Montefiore Medical Center at Hutchinson

The Bronx, New York, United States

Duke University Health System - Duke Clinic

Durham, North Carolina, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Roanoke Heart Institute

Roanoke, Virginia, United States

University of Washington School of Medicine

Seattle, Washington, United States

Providence Sacred Heart Children's Hospital

Spokane, Washington, United States

Saint Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, West Vlaanderen, Belgium

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED

Ribeirão Preto, São Paulo, Brazil

Instituto do Coração de São Paulo

São Paulo, São Paulo, Brazil

Vancouver General Hospital

Vancouver, British Columbia, Canada

Saint Boniface Hospital

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre - Halifax Infirmary

Halifax, Nova Scotia, Canada

Toronto Heart Centre

Toronto, Ontario, Canada

L' Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Hôpital régional de Rimouski

Rimouski, Quebec, Canada

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, Czechia

Institut Klinické a Experimentální Medicíny

Prague, Prague, Czechia

Fakultní Nemocnice u sv. Anny v Brně

Brno, South Moravian, Czechia

Aarhus Universitets Hospital

Aarhus N, Palle Juul-Jensens, Denmark

Alexandra General Hospital of Athens

Athens, Attica, Greece

Mater Misericordiae University Hospital

Dublin, Dublin, Ireland

The Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Ospedale San Donato

Arezzo, Arezzo, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence, Italy

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

Pisa, Pisa, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Utrecht, Netherlands

Middlemore Clinical Trials - Middlemore Hospital

Papatoetoe, Auckland, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Centro Hospitalar Universitário Lisboa Norte EPE- Hospital Santa Maria

Lisbon, Lisbon District, Portugal

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Gyeonggi-do, South Korea

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, La Coruña, Spain

Clinica Universidad de Navarra Madrid

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

National Amyloidosis Centre, Division of Medicine - Royal Free

London, England, United Kingdom

Richmond Pharmacology Ltd

London, England, United Kingdom

Clinical Research Directory

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)