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Clinical Trials in the USA / NCT04988386
Active, not recruiting Phase 3

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

NCT04988386 · tracked via the Priya Life Science USA tracker
Sponsor
Eidos Therapeutics, a BridgeBio company
Phase
Phase 3
Started
2021-10-27
Last updated
2025-10-14

Condition(s) studied

Amyloid Cardiomyopathy, Transthyretin-Related

Investigational drug(s) / intervention(s)

Acoramidis (AG10)

Acoramidis (AG10): Acoramidis (AG10) twice daily

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California
University of Colorado Hospital - Anschutz Medical Campus Aurora Colorado
Northwestern University Chicago Illinois
University of Chicago Medical Center Chicago Illinois
NorthShore University Health System Evanston Illinois
MedStar Medical Group Cardiology at Franklin Square Baltimore Maryland
Boston University Medical Center General Clinical Research Unit Boston Massachusetts
Mayo Clinic - Rochester Rochester Minnesota
Saint Luke's Hospital of Kansas City Kansas City Missouri
Washington University St Louis Missouri
New York University Langone Health New York New York
Columbia University Irving Medical Center New York New York
Laurelton Heart Specialists Rosedale New York
Montefiore Medical Center at Hutchinson The Bronx New York
Duke University Health System - Duke Clinic Durham North Carolina
Cleveland Clinic Main Campus Cleveland Ohio
Oregon Health & Science University Portland Oregon
Penn Presbyterian Medical Center Philadelphia Pennsylvania
University of Pittsburgh Medical Center (UPMC) Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
University of Texas Southwestern Medical Center Dallas Texas
University of Utah Salt Lake City Utah
Virginia Commonwealth University Health System Richmond Virginia
Roanoke Heart Institute Roanoke Virginia
University of Washington School of Medicine Seattle Washington
Providence Sacred Heart Children's Hospital Spokane Washington
Saint Vincent's Hospital Sydney Darlinghurst New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Royal Adelaide Hospital Adelaide South Australia
Royal Hobart Hospital Hobart Tasmania
Box Hill Hospital Box Hill Victoria
Fiona Stanley Hospital Murdoch Western Australia
Ziekenhuis Oost-Limburg Genk Limburg
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan Bruges West Vlaanderen
Instituto de Cardiologia do Rio Grande do Sul Porto Alegre Rio Grande do Sul
Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED Ribeirão Preto São Paulo
Instituto do Coração de São Paulo São Paulo São Paulo
Vancouver General Hospital Vancouver British Columbia
Saint Boniface Hospital Winnipeg Manitoba
Queen Elizabeth II Health Sciences Centre - Halifax Infirmary Halifax Nova Scotia

+ 32 more sites — see the full list on the official registry below.

More Eidos Therapeutics, a BridgeBio company trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04988386 on ClinicalTrials.gov ↗ ← All trials in the USA