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CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Primary Purpose

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eplontersen
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM) focused on measuring TTR, Amyloidosis, Cardiomyopathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent. If engaged in sexual relations of child-bearing potential, agree to use 1 highly effective contraceptive method
  • Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method
  • Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m Tc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed
  • End-diastolic interventricular septum thickness of > 12 millimeters (mm) on Screening echocardiogram
  • New York Heart Association (NYHA) class I-III

Exclusion Criteria:

  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
  • Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
  • Monoclonal gammopathy of undetermined significance (MGUS) and/or alterations in immunoglobulin free light chain (FLC) ratio unless fat, bone marrow, or heart biopsy confirming the absence of light chain and the presence of TTR protein by mass spectrometry or immunoelectron microscopy. For participants with chronic kidney disease (CKD) and without presence of monoclonal protein in blood and urine, the acceptable FLC ratio is 0.26-2.25. Results different from that may be discussed with local hematologist, Investigator and Medical Monitor if the risks associated with the biopsy outweigh the benefits
  • Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization
  • Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or ribonucleic acid (RNA) therapeutic (including small interfering ribonucleic acid [siRNA]; does not apply to COVID-19 mitochondrial [mRNA] vaccinations)
  • Current treatment with diflunisal, doxycycline, with or without ursodeoxycholic acid, and/or non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem). Participants receiving any of these agents must respect a wash-out period of 14 days before randomization.

Sites / Locations

  • Mayo Clinic - Arizona
  • Altman Clinical and Translational Research Institute Center for Clinical Research
  • Cedars-Sinai Medical Center
  • University of California, San Francisco (UCSF) - Medical Center
  • Stanford Hospital
  • University of Colorado Hospital - Anschutz Medical Campus
  • MedStar Washington Hospital Center
  • The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion
  • Cleveland Clinic Florida
  • Emory Heart and Vascular Center - Emory Clifton Campus
  • Piedmont Heart of Fayetteville
  • Northwestern University
  • The University of Chicago Medical Center
  • Loyola University Medical Center
  • Indiana University Health
  • University of Kansas Medical Center
  • Louisiana State University Health Sciences Center
  • Tulane University Heart and Vascular Institute
  • Ochsner Health System
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Boston University School of Medicine
  • Henry Ford Health System
  • Minneapolis Heart Institute
  • Mayo Clinic - Rochester
  • Saint Luke's Hospital of Kansas City
  • Barnes-Jewish Hospital
  • New York University Langone Cardiology Associates
  • Columbia University Irving Medical Center
  • Weill Cornell Medicine Cardiology
  • Laurelton Heart Specialists
  • The University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • Carl and Edyth Lindner Research Center at The Christ Hospital
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic Main Campus
  • The Ohio State University College of Medicine
  • Oregon Health and Science University
  • Lancaster General Hospital
  • Penn Presbyterian Medical Center
  • University of Pittsburgh Medical School
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • University of Texas Southwestern Medical Center
  • Houston Methodist Hospital
  • University of Utah
  • Virginia Commonwealth University (VCU)
  • University of Washington
  • University of Wisconsin - Madison
  • Froedtert & Medical College of Wisconsin
  • Instituto Cardiovascular de Buenos Aires
  • Hospital Italiano de Buenos Aires
  • Liverpool Hospital
  • The Westmead Institute for Medical Research
  • Princess Alexandra Hospital
  • Advara Heartcare
  • Royal Hobart Hospital
  • Box Hill Hospital
  • Advara HeartCare Murdoch
  • GenesisCare Murdoch
  • Advara HeartCare
  • GenesisCare Joondalup
  • Medizinische Universität Graz
  • Medizinische Universität Innsbruck
  • Medizinische Universität Wien
  • Ziekenhuis Oost-Limburg - Campus Sint-Jan
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
  • Universidade Estadual de Campinas
  • Hospital Moinhos de Vento
  • Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • A Beneficência Portuguesa de São Paulo - Unidade Mirante
  • Instituto Dante Pazzanese de Cardiologia
  • Instituto do Coração de São Paulo
  • University of Calgary
  • Gordon and Leslie Diamond Health Care Centre
  • University Hospital - London Health Sciences Centre
  • Toronto General Hospital
  • Centre Hospitalier de l'Université de Montréal (CHUM)
  • Hôpital Regional de Rimouski
  • Fakultní Nemocnice u sv. Anny v Brn
  • Vseobecna Fakultni Nemocnice v Praze
  • Institut Klinické a Experimentální Medicíny
  • Rigshospitalet
  • Odense Universitetshospital
  • Hôpital Rangueil
  • Hôpitaux Universitaires Henri Mondor
  • Centre Hospitalier Départemental Vendée
  • Hôpital de la Timone
  • Hôpital Haut-Lévêque
  • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
  • Universitätsklinikum des Saarlandes
  • Charité Campus Mitte
  • Charité Universitätsmedizin Berlin
  • Universitaetsklinikum Heidelberg - Zentrum fur Innere Medizin
  • Uniklinik Koln
  • Universitätsklinikum Münster
  • Universitätsklinikum Würzburg
  • Alexandra General Hospital
  • Rambam Health Care Campus
  • Hadassah University Hospital Ein Kerem
  • Kaplan Medical Center
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
  • Azienda Ospedaliero - Universitaria Careggi
  • Azienda Ospedale - Università di Padova
  • Fondazione IRCCS Policlinico San Matteo
  • Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica
  • Azienda Ospedaliera - Universitaria Sant' Andrea
  • Uwajima City Hospital
  • Hospital of the University of Occupational and Environmental Health
  • Kurume University Hospital
  • Sapporo Medical University Hospital
  • Saiseikai Fukuoka General Hospital
  • Kokura Memorial Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Shinshu University Hospital
  • Okayama University Hospital
  • Osaka Metropolitan University Hospital
  • Hamamatsu University Hospital
  • Keio University Hospital
  • Kumamoto University Hospital
  • Krakowski Szpital Specjalistyczny im. Jana Pawa II
  • Narodowy Instytut Kardiologii Stefana kardyna Wyszyskiego - Pastwowy Instytut Badawczy
  • Hospital da Senhora da Oliveira - Guimarães
  • Centro Hospitalar Universitário de Lisboa Central - Hospital de Santa Marta
  • Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio
  • Centro Hospitalar Universitário de São João
  • Veterans Affairs Caribbean Healthcare System
  • Hospital Universitari Vall d'Hebrón
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Clínico Universitario Virgen de la Arrixaca
  • Complejo Hospitalario Universitario de Santiago
  • Sahlgrenska Universitetssjukhuset
  • Skellefteå lasarett
  • Synexus - Scotland Clinical Research Centre
  • Synexus - Wales
  • Synexus Midlands Clinical Research Centre
  • Synexus - North Tees Clinical Research Centre
  • Synexus - Manchester Clinical Research Centre
  • Synexus - Merseyside Clinical Research Centre
  • Royal Free London NHS Foundation Trust
  • Richmond Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplontersen

Placebo

Arm Description

Eplontersen by subcutaneous injection once every 4 weeks

Eplontersen-matching placebo by subcutaneous injection once every 4 weeks

Outcomes

Primary Outcome Measures

Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140

Secondary Outcome Measures

Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 121
The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions.
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Week 121
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best, with a higher score equaling a better score.
CV Clinical Events up to Week 140
CV Mortality up to Week 140
All-Cause Mortality up to Week 140

Full Information

First Posted
October 21, 2019
Last Updated
August 1, 2023
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04136171
Brief Title
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Official Title
A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com.
Detailed Description
This is a multicenter, double-blind study in approximately 1400 participants, who will be randomized to receive subcutaneous (SC) injections of either eplontersen or placebo once every 4 weeks. Participants will also receive daily supplemental doses of the recommended daily allowance of vitamin A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Keywords
TTR, Amyloidosis, Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eplontersen
Arm Type
Experimental
Arm Description
Eplontersen by subcutaneous injection once every 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eplontersen-matching placebo by subcutaneous injection once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Eplontersen
Other Intervention Name(s)
ION-682884, AKCEA-TTR-LRx, IONIS-TTR-LRx
Intervention Description
Eplontersen by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Eplontersen-matching placebo by subcutaneous injection
Primary Outcome Measure Information:
Title
Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140
Time Frame
Baseline up to Week 140
Secondary Outcome Measure Information:
Title
Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 121
Description
The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions.
Time Frame
Baseline to Week 121
Title
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Week 121
Description
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best, with a higher score equaling a better score.
Time Frame
Baseline to Week 121
Title
CV Clinical Events up to Week 140
Time Frame
Baseline up to Week 140
Title
CV Mortality up to Week 140
Time Frame
Baseline up to Week 140
Title
All-Cause Mortality up to Week 140
Time Frame
Baseline up to Week 140

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent. If engaged in sexual relations of child-bearing potential, agree to use 1 highly effective contraceptive method Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m Tc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed End-diastolic interventricular septum thickness of > 12 millimeters (mm) on Screening echocardiogram New York Heart Association (NYHA) class I-III Exclusion Criteria: Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease Monoclonal gammopathy of undetermined significance (MGUS) and/or alterations in immunoglobulin free light chain (FLC) ratio unless fat, bone marrow, or heart biopsy confirming the absence of light chain and the presence of TTR protein by mass spectrometry or immunoelectron microscopy. For participants with chronic kidney disease (CKD) and without presence of monoclonal protein in blood and urine, the acceptable FLC ratio is 0.26-2.25. Results different from that may be discussed with local hematologist, Investigator and Medical Monitor if the risks associated with the biopsy outweigh the benefits Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or ribonucleic acid (RNA) therapeutic (including small interfering ribonucleic acid [siRNA]; does not apply to COVID-19 mitochondrial [mRNA] vaccinations) Current treatment with diflunisal, doxycycline, with or without ursodeoxycholic acid, and/or non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem). Participants receiving any of these agents must respect a wash-out period of 14 days before randomization.
Facility Information:
Facility Name
Mayo Clinic - Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Altman Clinical and Translational Research Institute Center for Clinical Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, San Francisco (UCSF) - Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory Heart and Vascular Center - Emory Clifton Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Piedmont Heart of Fayetteville
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University Heart and Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University Langone Cardiology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10034
Country
United States
Facility Name
Weill Cornell Medicine Cardiology
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Laurelton Heart Specialists
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carl and Edyth Lindner Research Center at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical School
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Commonwealth University (VCU)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Froedtert & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Instituto Cardiovascular de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1428ART
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autónoma De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
The Westmead Institute for Medical Research
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Advara Heartcare
City
Leabrook
State/Province
South Australia
ZIP/Postal Code
5068
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Advara HeartCare Murdoch
City
Murdoch
State/Province
West Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
GenesisCare Murdoch
City
Murdoch
State/Province
West Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Advara HeartCare
City
Joondalup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Facility Name
GenesisCare Joondalup
City
Joondalup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Ziekenhuis Oost-Limburg - Campus Sint-Jan
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universidade Estadual de Campinas
City
Campinas
ZIP/Postal Code
13083881
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED
City
Ribeirão Preto
ZIP/Postal Code
14026-900
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
City
Ribeirão Preto
ZIP/Postal Code
14040-030
Country
Brazil
Facility Name
A Beneficência Portuguesa de São Paulo - Unidade Mirante
City
São Paulo
ZIP/Postal Code
01323-030
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Facility Name
Instituto do Coração de São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
University Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
Hôpital Regional de Rimouski
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Fakultní Nemocnice u sv. Anny v Brn
City
Brno
State/Province
South Moravian
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Institut Klinické a Experimentální Medicíny
City
Prague
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hôpital Rangueil
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpitaux Universitaires Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg - Zentrum fur Innere Medizin
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Uniklinik Koln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Facility Name
Alexandra General Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedale - Università di Padova
City
Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria Sant' Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Uwajima City Hospital
City
Uwajima-shi
State/Province
Ehime
ZIP/Postal Code
798-8510
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
State/Province
Hukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Hukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi,
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawa II
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Narodowy Instytut Kardiologii Stefana kardyna Wyszyskiego - Pastwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Hospital da Senhora da Oliveira - Guimarães
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Universitário de Lisboa Central - Hospital de Santa Marta
City
Lisbon
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar Universitário de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Veterans Affairs Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skellefteå lasarett
City
Skellefteå
ZIP/Postal Code
931 86
Country
Sweden
Facility Name
Synexus - Scotland Clinical Research Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Synexus - Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Centre
City
Edgbaston
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Synexus - North Tees Clinical Research Centre
City
Hexham
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Synexus - Manchester Clinical Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Synexus - Merseyside Clinical Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
HR3M+6R
Country
United Kingdom
Facility Name
Richmond Pharmacology
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.cardio-ttransform.com/
Description
CARDIO-TTRansform Website

Learn more about this trial

CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

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