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Studies

Interventional Active not recruiting Phase 3

NCT04988386 on ClinicalTrials.gov

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

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)

  • Sponsor: Eidos Therapeutics
  • Enrollment: 389 (Actual)
  • Study start: 2021-10-27 (Actual)
  • Primary completion: 2028-04-15 (Estimated)
  • Study completion: 2028-05-15 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: Open-label study extension study from the AG 10-301 double-blind study.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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)

Conditions

  • Amyloid Cardiomyopathy, Transthyretin-Related

Intervention / Treatment

  • Drug: Acoramidis (AG10)

Primary Outcome Measures

  • Incidence of treatment-emergent Adverse Events [Safety and Tolerability] (60 months)
    Incidence of each treatment-emergent adverse events measured over 60 Months or study completion

Countries

Australia, Belgium, Brazil, Canada, Czechia, Denmark, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Portugal, South Korea, Spain, United Kingdom, United States

Locations and Investigators

  • Cedars-Sinai Medical Center, Los Angeles, United States
  • University of Colorado Hospital - Anschutz Medical Campus, Aurora, United States
  • Northwestern University, Chicago, United States
  • University of Chicago Medical Center, Chicago, United States
  • NorthShore University Health System, Evanston, United States
  • MedStar Medical Group Cardiology at Franklin Square, Baltimore, United States
  • Boston University Medical Center General Clinical Research Unit, Boston, United States
  • Mayo Clinic - Rochester, Rochester, United States
  • Saint Luke's Hospital of Kansas City, Kansas City, United States
  • Washington University, St Louis, United States
  • New York University Langone Health, New York, United States
  • Columbia University Irving Medical Center, New York, United States
  • Laurelton Heart Specialists, Rosedale, United States
  • Montefiore Medical Center at Hutchinson, The Bronx, United States
  • Duke University Health System - Duke Clinic, Durham, United States
  • Cleveland Clinic Main Campus, Cleveland, United States
  • Oregon Health & Science University, Portland, United States
  • Penn Presbyterian Medical Center, Philadelphia, United States
  • University of Pittsburgh Medical Center (UPMC), Pittsburgh, United States
  • Medical University of South Carolina, Charleston, United States
  • University of Texas Southwestern Medical Center, Dallas, United States
  • University of Utah, Salt Lake City, United States
  • Virginia Commonwealth University Health System, Richmond, United States
  • Roanoke Heart Institute, Roanoke, United States
  • University of Washington School of Medicine, Seattle, United States
  • Providence Sacred Heart Children's Hospital, Spokane, United States
  • Saint Vincent's Hospital Sydney, Darlinghurst, Australia
  • Princess Alexandra Hospital, Woolloongabba, Australia
  • Royal Adelaide Hospital, Adelaide, Australia
  • Royal Hobart Hospital, Hobart, Australia
  • Box Hill Hospital, Box Hill, Australia
  • Fiona Stanley Hospital, Murdoch, Australia
  • Ziekenhuis Oost-Limburg, Genk, Belgium
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan, Bruges, Belgium
  • Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil
  • Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED, Ribeirão Preto, Brazil
  • Instituto do Coração de São Paulo, São Paulo, Brazil
  • Vancouver General Hospital, Vancouver, Canada
  • Saint Boniface Hospital, Winnipeg, Canada
  • Queen Elizabeth II Health Sciences Centre - Halifax Infirmary, Halifax, Canada
  • Toronto Heart Centre, Toronto, Canada
  • L' Institut de Cardiologie de Montréal, Montreal, Canada
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada
  • Hôpital du Sacré-Coeur de Montréal, Montreal, Canada
  • Hôpital régional de Rimouski, Rimouski, Canada
  • Vseobecna Fakultni Nemocnice v Praze, Prague, Czechia
  • Institut Klinické a Experimentální Medicíny, Prague, Czechia
  • Fakultní Nemocnice u sv. Anny v BrnÄ›, Brno, Czechia
  • Aarhus Universitets Hospital, Aarhus N, Denmark
  • Alexandra General Hospital of Athens, Athens, Greece

And 22 other sites.