Transthyretin Amyloid Cardiomyopathy Clinical Trial
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Summary
The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.
Eligibility Criteria
Inclusion Criteria:
Centrally confirmed diagnosis of ATTR-CM with either wild-type or variant TTR genotype
End-diastolic interventricular septal wall thickness ≥ 11 mm for women or ≥ 12 mm for men on echocardiography measured at Screening
NT-proBNP > 2000 pg/mL at Screening
Treatment with a loop diuretic for at least 30 days prior to Screening
History of heart failure NYHA Class II-IV at Screening
Life expectancy of ≥ 6 months as per the Investigator's judgment
Males and females of childbearing ability must use contraception
Exclusion Criteria:
Known leptomeningeal amyloidosis
Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis
Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment
LVEF < 30% on echocardiography
Renal failure requiring dialysis or an eGFR < 20 mL/min/1.73 m2 at Screening
Polyneuropathy with PND score IV
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There are 230 Locations for this study
Irvine California, 92614, United States
La Jolla California, 92037, United States
Palo Alto California, 94304, United States
San Francisco California, 94143, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20010, United States
Jacksonville Florida, 32224, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Kansas City Kansas, 66160, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02118, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55421, United States
Rochester Minnesota, 55905, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
New York New York, 10032, United States
Stony Brook New York, 11794, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19104, United States
Providence Rhode Island, 02908, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37232, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Falls Church Virginia, 22042, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
Madison Wisconsin, 53705, United States
Buenos Aires , 1425, Argentina
Buenos Aires , C1110, Argentina
Caba , C1006, Argentina
Caba , C1428, Argentina
Ciudad Autonoma Buenos Aires , C1181, Argentina
Cordoba , X5016, Argentina
Pilar , B1629, Argentina
Box Hill , 3128, Australia
Brisbane , 4102, Australia
Darlinghurst , 2010, Australia
Joondalup , 6027, Australia
Melbourne , 3004, Australia
Westmead , 2145, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Wels , 4600, Austria
Wien , 1090, Austria
Wien , 1160, Austria
Bruges , 8000, Belgium
Brussels , 1070, Belgium
Genk , 3600, Belgium
Campinas , 13083, Brazil
Fortaleza , 60430, Brazil
Porto Alegre , 90560, Brazil
Ribeirão Preto , 14026, Brazil
Ribeirão Preto , 14051, Brazil
Rio de Janeiro , 20551, Brazil
Rio de Janeiro , 22270, Brazil
Sao Paulo , 05403, Brazil
Sao Paulo , 05652, Brazil
São Paulo , 01323, Brazil
São Paulo , 01409, Brazil
São Paulo , 04012, Brazil
Calgary Alberta, T2N 1, Canada
Vancouver British Columbia, V5Z 1, Canada
Winnipeg Manitoba, R2H 2, Canada
London Ontario, N6C 2, Canada
Toronto Ontario, M5G 2, Canada
Chicoutimi Quebec, G7H 5, Canada
Montréal Quebec, H1T 1, Canada
Montréal Quebec, H2X 0, Canada
Rimouski Quebec, G5L 5, Canada
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10003, China
Beijing , 10019, China
Beijing , 10073, China
Changsha , 43003, China
Chengdu , 61000, China
Chengdu , 61007, China
Chongqing , 40004, China
Dalian , 11601, China
Fuzhou , 35000, China
Guangzhou , 51008, China
Guiyang , 55004, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Harbin , 15000, China
Hefei , 23000, China
Jinan , 25002, China
Nanjing , 21002, China
Shanghai , 20003, China
Tianjin , 30022, China
Wuhan , 43002, China
Wuhan , 43003, China
Xi'an , 71006, China
Brno , 656 9, Czechia
Praha 4 , 140 0, Czechia
Praha , 128 0, Czechia
Aarhus , 8200, Denmark
Copenhagen , DK-21, Denmark
Odense C , 5000, Denmark
Bron , 69677, France
Chambray Les Tours , 37170, France
Créteil Cédex , 94010, France
Marseille , 13005, France
Montpellier , 34295, France
Paris Cedex 13 , 75651, France
Paris , 75018, France
Pessac , 33604, France
Poitiers , 86021, France
Rennes Cedex 9 , 35033, France
Saint-Herblain , 44093, France
Toulouse , 31059, France
Bonn , 53127, Germany
Cologne , 50937, Germany
Essen , 45147, Germany
Gießen , 35392, Germany
Greifwald , 17489, Germany
Göttingen , 37075, Germany
Hamburg , 22767, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Homburg , 66421, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
München , 81377, Germany
Münster , 48149, Germany
Würzburg , 97078, Germany
Würzburg , 97078, Germany
Athens , 11528, Greece
Athens , 11528, Greece
Dublin , 7, Ireland
Dublin , 8, Ireland
Beer Yaakov , 70300, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Jerusalem , 93722, Israel
Petah Tikva , 49414, Israel
Rehovot , 76100, Israel
Bologna , 40138, Italy
Ferrara , 44124, Italy
Florence , 50134, Italy
Forli , 47121, Italy
Messina , 98124, Italy
Milano , 20122, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Pavia , 27100, Italy
Pisa , 56124, Italy
Roma , 00189, Italy
Torino , 10154, Italy
Trieste , 34128, Italy
Bunkyo-ku , 113-8, Japan
Kumamoto-shi , 860-8, Japan
Kurume-shi , 830-0, Japan
Kyoto-shi , 602-8, Japan
Matsumoto-shi , 390-8, Japan
Sapporo-shi , 060-8, Japan
Shinjuku-ku , 160-8, Japan
Suita-shi , 564-8, Japan
Busan , 49241, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 5505, Korea, Republic of
Wonju-si , 26426, Korea, Republic of
Groningen , 9713 , Netherlands
Maastricht , 6229, Netherlands
Rotterdam , 3015 , Netherlands
Utrecht , 3584, Netherlands
Auckland , 2025, New Zealand
Lørenskog , N-147, Norway
Oslo , 0372, Norway
Trondheim , 7030, Norway
Gdansk , 80-95, Poland
Krakow , 31-20, Poland
Poznań , 61-84, Poland
Warszawa , 02-09, Poland
Warszawa , 04-62, Poland
Barcelona , 8035, Spain
El Palmar , 30120, Spain
Jaen , 23007, Spain
L'Hospitalet de Llobregat , 08907, Spain
La Coruna , 15006, Spain
Madrid , 28027, Spain
Majadahonda , 28222, Spain
Malaga , 29010, Spain
Palma de Mallorca , 07198, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Santiago De Compostela-Coruña , 15706, Spain
Valencia , 46010, Spain
Göteborg , 41345, Sweden
Lund , 221 8, Sweden
Stockholm , 171 6, Sweden
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Luzern , 6000, Switzerland
St.Gallen , 9007, Switzerland
Zürich , 8006, Switzerland
New Taipei City , 220, Taiwan
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Taipei , 10002, Taiwan
Taipei , 11220, Taiwan
Ankara , 06230, Turkey
Dinar , 03400, Turkey
Eskisehir , 26480, Turkey
Istanbul , 34180, Turkey
Istanbul , 34303, Turkey
Izmir , 35340, Turkey
Mersin , 33079, Turkey
Birmingham , B15 2, United Kingdom
Cardiff , CF15 , United Kingdom
Glasgow , G20 0, United Kingdom
Hexham , NE46 , United Kingdom
London , NW3 2, United Kingdom
London , SE1 1, United Kingdom
London , SW17 , United Kingdom
Manchester , M15 6, United Kingdom
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