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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eidos Therapeutics, a BridgeBio company
Study ID
NCT04988386
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Amyloid Cardiomyopathy, Transthyretin-Related

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Oct 27, 2021
Status verified
Oct 2025
Primary completion
Apr 15, 2028
Completion
May 15, 2028

Study Design

Enrollment
389 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AG10
    Open-label study all participants will receive AG10 during this study.

Primary Outcome Measure

Incidence of treatment-emergent Adverse Events [Safety and Tolerability] [ Time Frame: 60 months ]

Locations (26)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of Colorado Hospital - Anschutz Medical CampusAuroraColorado80045-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Medical CenterChicagoIllinois60637-
NorthShore University Health SystemEvanstonIllinois60201-
MedStar Medical Group Cardiology at Franklin SquareBaltimoreMaryland21237-
Boston University Medical Center General Clinical Research UnitBostonMassachusetts02118-
Mayo Clinic - RochesterRochesterMinnesota55905-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Washington UniversitySt LouisMissouri63110-
Columbia University Irving Medical CenterNew YorkNew York10032-
New York University Langone HealthNew YorkNew York10016-
Laurelton Heart SpecialistsRosedaleNew York11422-
Montefiore Medical Center at HutchinsonThe BronxNew York10461-
Duke University Health System - Duke ClinicDurhamNorth Carolina27710-
Cleveland Clinic Main CampusClevelandOhio44195-
Oregon Health & Science UniversityPortlandOregon97239-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15213-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of UtahSalt Lake CityUtah84132-
Virginia Commonwealth University Health SystemRichmondVirginia23219-
Roanoke Heart InstituteRoanokeVirginia24014-
University of Washington School of MedicineSeattleWashington98195-
Providence Sacred Heart Children's HospitalSpokaneWashington99204-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Colorado Hospital - Anschutz Medical Campus· Aurora, CONorthwestern University· Chicago, ILUniversity of Chicago Medical Center· Chicago, ILNorthShore University Health System· Evanston, ILMedStar Medical Group Cardiology at Franklin Square· Baltimore, MD