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NCT05667493Enrolling by invitationPhase 3

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1400 (estimated)
First submitted
12 Jul 2022
Start date
30 Nov 2022
Primary completion date
Aug 2029
Lead sponsor
Ionis Pharmaceuticals, Inc.
Diseases
Amyloidosis
NCT number
NCT05667493
EudraCT number
2022-000826-74

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1400
  • From 30 Nov 2022 to the primary completion date, Aug 2029
  • 132 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
  • Have any new condition or worsening of an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.

Who the study is looking for

  • Satisfactory completion of Treatment Period and the End of Treatment Visit of the Index Study (ION-682884-CS2) OR diagnosis of ATTR-CM and satisfactory participation on ISIS 420915- CS101 study as judged by the Investigator and Sponsor.
  • Investigator is willing to treat the participant with open-label eplontersen.
  • Willingness to adhere to vitamin A supplementation per protocol.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (132)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Instituto Cardiovascular de Buenos Aires
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Buenos AiresArgentinaUnknown status
Medizinische Universität Graz
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GrazAustriaUnknown status
Medizinische Universität Innsbruck
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InnsbruckAustriaUnknown status
Medizinische Universität Wien
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ViennaAustriaUnknown status
Box Hill Hospital
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ClaytonAustraliaUnknown status
Royal Hobart Hospital
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HobartAustraliaUnknown status
Advara HeartCare Joondalup
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JoondalupAustraliaUnknown status
Advara HeartCare
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JoondalupAustraliaUnknown status
Advara HeartCare Leabrook
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LeabrookAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Advara HeartCare Murdoch
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MurdochAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
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BrugesBelgiumUnknown status
Ziekenhuis Oost-Limburg - Campus Sint-Jan
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LimbourgBelgiumUnknown status
Hospital Moinhos de Vento
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Porto AlegreBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Ribeirão PretoBrazilUnknown status
Instituto Dante Pazzanese de Cardiologia
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São PauloBrazilUnknown status
Universidade Estadual de Campinas
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São PauloBrazilUnknown status
A Beneficência Portuguesa de São Paulo - Unidade Mirante
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São PauloBrazilUnknown status
Instituto do Coração de São Paulo
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São PauloBrazilUnknown status
Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED
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São PauloBrazilUnknown status
University Of Calgary
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CalgaryCanadaUnknown status
University Hospital - London Health Sciences Centre
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LondonCanadaUnknown status
Centre Hospitalier de l'Universite de Montreal (CHUM)
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MontrealCanadaUnknown status
Hôpital régional de Rimouski
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RimouskiCanadaUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
Gordon and Leslie Diamond Health Care Centre
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VancouverCanadaUnknown status
Fakultni nemocnice u sv. Anny v Brne
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BrnoCzechiaUnknown status
Institut klinicke a experimentalni mediciny
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PragueCzechiaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaUnknown status
Uniklinik Köln
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CologneGermanyUnknown status
Universitaetsklinikum Heidelberg - Zentrum für Innere Medizin
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HeidelbergGermanyUnknown status
Universitätsklinikum des Saarlandes
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HomburgGermanyUnknown status
Universitätsklinikum Münster
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MünsterGermanyUnknown status
Universitätsklinikum Würzburg
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WürzburgGermanyUnknown status
Rigshospitalet
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CopenhagenDenmarkUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario Puerta de Hierro
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MajadahondaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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MurciaSpainUnknown status
Complejo Hospitalario Universitario de Santiago (CHUS)
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Santiago de CompostelaSpainUnknown status
Hôpitaux Universitaires Henri Mondor
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CréteilFranceUnknown status
Centre Hospitalier Départemental Vendée
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La Roche-sur-YonFranceUnknown status
Hopital de la Timone
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MarseilleFranceUnknown status
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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NantesFranceUnknown status
Hopital Haut-Leveque
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PessacFranceUnknown status
Hopital Rangueil
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ToulouseFranceUnknown status
AES - Synexus - Scotland Clinical Research Centre
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BellshillUnited KingdomUnknown status
AES - Synexus - Wales
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CardiffUnited KingdomUnknown status
AES - Synexus - Midlands
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EdgbastonUnited KingdomUnknown status
Royal Free London NHS Foundation Trust
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HampsteadUnited KingdomUnknown status
Synexus Merseyside Clinical Research Centre
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LiverpoolUnited KingdomUnknown status
Richmond Pharmacology
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LondonUnited KingdomUnknown status
Synexus Manchester Clinical Research Centre
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ManchesterUnited KingdomUnknown status
Synexus - Merseyside Clinical Research Centre
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ManchesterUnited KingdomUnknown status
General Hospital of Athens - Alexandra
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AthensGreeceUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelUnknown status
Kaplan Medical Center
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RehovotIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyUnknown status
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyUnknown status
Azienda Ospedale Università di Padova
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PadovaItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica
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PisaItalyUnknown status
Azienda Ospedaliera Universitaria Sant'Andrea
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RomaItalyUnknown status
Saiseikai Fukuoka General Hospital
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FukuokaJapanUnknown status
Hamamatsu University Hospital
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HamamatsuJapanUnknown status
Kumamoto University Hospital
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KumamotoJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
Kurume University Hospital
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Kurume-shiJapanUnknown status
Shinshu University Hospital
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MatsumotoJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Osaka Metropolitan University Hospital
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OsakaJapanUnknown status
Sapporo Medical University Hospital
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SapporoJapanUnknown status
Keio University Hospital
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Shinjuku-kuJapanUnknown status
Krakowski Szpital Specjalistyczny im. Jana Pawła II
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KrakówPolandUnknown status
Unidade Local de Saude do Alto Ave, E. P. E (Hospital da Senhora da Oliveira Guimaraes)
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GuimarãesPortugalUnknown status
Hospital da Senhora da Oliveira
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GuimarãesPortugalUnknown status
Unidade Local de Saúde de São José, E. P. E - Hospital de Santa Marta
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LisbonPortugalUnknown status
Unidade Local de Saude de Santo Antonio, E. P. E - Hospital Geral de Santo Antonio
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PortoPortugalUnknown status
Unidade Local de Saúde de São João, EPE
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PortoPortugalUnknown status
Centro Hospitalar Universitário de São João
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PortoPortugalUnknown status
Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio
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PortoPortugalUnknown status
Sahlgrenska Universitetssjukhuset
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GothenburgSwedenUnknown status
Skellefteå lasarett
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SkellefteåSwedenUnknown status
Emory Heart and Vascular Center - Emory Clifton Campus
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AtlantaUnited StatesUnknown status
Piedmont Heart of Fayetteville
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AtlantaUnited StatesUnknown status
University of Colorado Hospital - Anschutz Medical Campus
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AuroraUnited StatesUnknown status
University of Maryland Medical Center
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BaltimoreUnited StatesUnknown status
Cedars-Sinai Medical Center
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Beverly HillsUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Boston University School of Medicine
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BostonUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Carl and Edyth Lindner Research Center at The Christ Hospital
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CincinnatiUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Cleveland Clinic - Main Campus
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ClevelandUnited StatesUnknown status
The Ohio State University College of Medicine
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Piedmont Atlanta Hospital
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FayettevilleUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
Indiana University Health University Hospital
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IndianapolisUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University of Kansas Medical Center (KUMC)
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Kansas CityUnited StatesUnknown status
Altman Clinical and Translational Research Institute - Center for Clinical Research
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La JollaUnited StatesUnknown status
Lancaster General Hospital
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LancasterUnited StatesUnknown status
University of Wisconsin - Madison
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MadisonUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Allina Health Minneapolis Heart Institute - Abbott Northwestern's Heart Hospital
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MinneapolisUnited StatesUnknown status
Vanderbilt Heart and Vascular Institute
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NashvilleUnited StatesUnknown status
New York University Langone Cardiology Associates
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New YorkUnited StatesUnknown status
Columbia University Irving Medical Center
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New YorkUnited StatesUnknown status
Weill Cornell Medicine Cardiology
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New YorkUnited StatesUnknown status
Penn Presbyterian Medical Center
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PhiladelphiaUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Virginia Commonwealth University
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RichmondUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University Of California San Francisco Urology Practice
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San FranciscoUnited StatesUnknown status
Mayo Clinic
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ScottsdaleUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Stanford University (Leland Stanford Junior University)
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StanfordUnited StatesUnknown status
Barnes-Jewish Hospital
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St LouisUnited StatesUnknown status
The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion
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Washington D.C.United StatesUnknown status
MedStar Washington Hospital Center
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Washington D.C.United StatesUnknown status
Cleveland Clinic Florida
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WestonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.