Transthyretin Amyloid Cardiomyopathy Clinical Trial

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

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)

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Full Description

The primary objective of this prospective multi-center, open-label study is to evaluate the long-term safety and tolerability of acoramidis in the context of background heart failure therapy. Selected secondary efficacy endpoints and exploratory pharmacokinetic, pharmacodynamic/biomarker endpoints may also be assessed. All participants who complete 30 months of blinded study treatment and the Month 30 assessments of the double-blind treatment period of the Phase 3 ATTRibute-CM trial (AG10-301) may be eligible to participate in this Open Label Extension (OLE) study of acoramidis. The Day 1 visit in Study AG10-304 may be the same day as the Month 30 visit in Study AG10-301. Under these circumstances, the last dose of Investigational Medicinal Product (IMP) in Study AG10-301 will be the night before the day of the Month 30 visit and the first dose of acoramidis in Study AG10-304 will be during the Study AG10-304 Day 1 visit after baseline assessments have been completed.

Currently, tafamidis is approved for the treatment of ATTR-CM in some regions. Participants are not allowed to be treated with tafamidis or any other ATTR-CM-specific approved or investigational treatments, or therapies used off-label or as non-prescription supplements for ATTR-CM at any time during the study. If participants choose treatment with a prohibited medication, they may be asked to discontinue acoramidis and they may be asked to discontinue/withdraw from the study. Under these circumstances, participants will be asked to complete an early termination visit, and a follow-up visit prior to discontinuation/withdrawal.

Participants are not permitted to participate in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing and throughout Study AG10-304. Participants who choose to participate in another interventional clinical trial may be asked to withdraw from acoramidis and/or the study. In such cases, participants will be asked to complete an early termination visit and a follow-up visit. Participation in observational and/or registry studies should be discussed with the Medical Monitor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures.
Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
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:

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.
Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
Has had a heart and/or liver transplant or is on the heart transplantation list within the year prior to Day 1
Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for implantation of a CMAD
Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
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.
Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.
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.
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.
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.
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.
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.

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

545

Study ID:

NCT04988386

Recruitment Status:

Enrolling by invitation

Sponsor:

Eidos Therapeutics, a BridgeBio company

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There are 42 Locations for this study

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Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of Colorado Hospital - Anschutz Medical Campus
Aurora Colorado, 80045, United States
Northwestern University
Chicago Illinois, 60611, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
NorthShore University Health System
Evanston Illinois, 60201, United States
MedStar Medical Group Cardiology at Franklin Square Medical Center
Baltimore Maryland, 21237, United States
Boston University School of Medicine
Boston Massachusetts, 02118, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Saint Luke's Hospital - Kansas City
Kansas City Missouri, 64111, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Montefiore Medical Center
Bronx New York, 10461, United States
New York University Langone Health
New York New York, 10010, United States
Columbia University Medical Center
New York New York, 10032, United States
Laurelton Heart Specialist
Rosedale New York, 11422, United States
Duke University Health System
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Penn Presbyterian Medical Center
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
The Medical University of South Carolina
Charleston South Carolina, 29425, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
University of Utah
Salt Lake City Utah, 84132, United States
Virginia Commonwealth University Medical Center
Richmond Virginia, 23298, United States
Carilion Clinic Roanoke Heart Institute
Roanoke Virginia, 24014, United States
University of Washington School of Medicine
Seattle Washington, 98195, United States
Providence Sacred Heart Medical Center
Spokane Washington, 99204, United States
Royal Adelaide Hospital
Adelaide , , Australia
Box Hill Hospital
Box Hill , , Australia
Royal Hobart Hospital
Hobart , , Australia
Fiona Stanley Hospital
Murdoch , , Australia
Saint Vincent's Hospital Sydney
Sydney , 2010, Australia
Princess Alexandra Hospital
Woolloongabba , , Australia
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk Limburg, , Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
Brugge West Vlaanderen, , Belgium
Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED
Ribeirão Preto Sao Paulo, 14026, Brazil
Instituto do Coração de São Paulo
São Paulo Sao Paulo, , Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre , , Brazil
University of British Columbia
Vancouver British Columbia, V5Z 1, Canada
CancerCare Manitoba - Saint Boniface Hospital
Winnipeg Manitoba, R2H 2, Canada
Queen Elizabeth II Health Sciences Centre - Halifax Infirmary
Halifax Nova Scotia, B3H 3, Canada
Toronto Heart Centre
Toronto Ontario, M4P I, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal Quebec, H2X 0, Canada
Hôpital du Sacré-Coeur de Montréal
Montréal Quebec, H4J 1, Canada
Hôpital régional de Rimouski
Rimouski Quebec, G5L 5, Canada
Montreal Heart Institute
Montréal , , Canada
Institut Klinické a Experimentální Medicíny, Klinika Kardiologie
Praha Prague, , Czechia
Vseobecna Fakultni Nemocnice v Praze
Praha Prague, , Czechia
Fakultní Nemocnice u sv. Anny v Brně
Brno South Moravian, , Czechia
Aarhus Universitetshospital
Aarhus Dinamarca, 8200, Denmark
Alexandra General Hospital of Athens
Athens Attica, , Greece
Mater Misericordiae University Hospital
Dublin , , Ireland
Hadassah University Hospital Ein Kerem
Jerusalem , , Israel
The Chaim Sheba Medical Center
Tel Hashomer , , Israel
Ospedale San Donato
Arezzo , , Italy
Azienda Ospedaliero - Universitaria Careggi
Firenze , , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica
Pisa , , Italy
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-Do, 13620, Korea, Republic of
Seoul National University Hospital
Seoul Gyeonggi-Do, 13620, Korea, Republic of
Universitair Medisch Centrum Groningen
Groningen , , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , , Netherlands
Middlemore Hospital
Papatoetoe Auckland, 2025, New Zealand
Waikato Hospital
Hamilton Waikato, 3240, New Zealand
Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
Lisboa , , Portugal
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago De Compostela La Coruña, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, , Spain
Clínica Universidad de Navarra
Pamplona Navarra, , Spain
Clinica Universidad de Navarra Madrid
Madrid , , Spain
Hospital Son Llàtzer
Palma De Mallorca , , Spain
Hospital Clínico Universitario de Valencia
Valencia , , Spain
Royal Free London NHS Foundation Trust
London England, NW3 2, United Kingdom
Richmond Pharmacology
London , SE1 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

545

Study ID:

NCT04988386

Recruitment Status:

Enrolling by invitation

Sponsor:


Eidos Therapeutics, a BridgeBio company

How clear is this clinincal trial information?

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