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.

View Eligibility Criteria

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

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

1000

Study ID:

NCT06183931

Recruitment Status:

Recruiting

Sponsor:

Alexion Pharmaceuticals, Inc.

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There are 228 Locations for this study

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Irvine California, 92614, United States
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La Jolla California, 92037, United States
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Palo Alto California, 94304, United States
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San Francisco California, 94143, United States
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Aurora Colorado, 80045, United States
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Washington District of Columbia, 20010, United States
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Jacksonville Florida, 32224, United States
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Weston Florida, 33331, United States
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Atlanta Georgia, 30309, United States
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Atlanta Georgia, 30322, United States
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Chicago Illinois, 60611, United States
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Chicago Illinois, 60637, United States
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Indianapolis Indiana, 46202, United States
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Kansas City Kansas, 66160, United States
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Boston Massachusetts, 02115, United States
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Boston Massachusetts, 02118, United States
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Minneapolis Minnesota, 55417, United States
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Minneapolis Minnesota, 55421, United States
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Rochester Minnesota, 55905, United States
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Kansas City Missouri, 64111, United States
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Saint Louis Missouri, 63110, United States
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New York New York, 10016, United States
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New York New York, 10032, United States
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Stony Brook New York, 11794, United States
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Chapel Hill North Carolina, 27599, United States
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Durham North Carolina, 27705, United States
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Cleveland Ohio, 44195, United States
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Columbus Ohio, 43210, United States
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Portland Oregon, 97239, United States
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Danville Pennsylvania, 17822, United States
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Philadelphia Pennsylvania, 19104, United States
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Providence Rhode Island, 02908, United States
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Charleston South Carolina, 29425, United States
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Greenville South Carolina, 29605, United States
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Nashville Tennessee, 37232, United States
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Fort Worth Texas, 76104, United States
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Houston Texas, 77030, United States
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Salt Lake City Utah, 84132, United States
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Falls Church Virginia, 22042, United States
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Richmond Virginia, 23298, United States
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Seattle Washington, 98195, United States
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Madison Wisconsin, 53705, United States
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Buenos Aires , 1425, Argentina
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Buenos Aires , C1110, Argentina
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Caba , C1006, Argentina
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Caba , C1428, Argentina
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Ciudad Autonoma Buenos Aires , C1181, Argentina
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Cordoba , X5016, Argentina
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Pilar , B1629, Argentina
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Box Hill , 3128, Australia
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Brisbane , 4102, Australia
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Darlinghurst , 2010, Australia
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Joondalup , 6027, Australia
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Melbourne , 3004, Australia
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Westmead , 2145, Australia
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Wels , 4600, Austria
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Wien , 1090, Austria
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Wien , 1160, Austria
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Bruges , 8000, Belgium
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Brussels , 1070, Belgium
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Genk , 3600, Belgium
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Campinas , 13083, Brazil
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Fortaleza , 60430, Brazil
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Porto Alegre , 90560, Brazil
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Ribeirão Preto , 14026, Brazil
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Ribeirão Preto , 14051, Brazil
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Rio de Janeiro , 20551, Brazil
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Rio de Janeiro , 22270, Brazil
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Sao Paulo , 05403, Brazil
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Sao Paulo , 05652, Brazil
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São Paulo , 01323, Brazil
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São Paulo , 01409, Brazil
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São Paulo , 04012, Brazil
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Calgary Alberta, T2N 1, Canada
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Vancouver British Columbia, V5Z 1, Canada
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Winnipeg Manitoba, R2H 2, Canada
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London Ontario, N6C 2, Canada
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Toronto Ontario, M5G 2, Canada
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Chicoutimi Quebec, G7H 5, Canada
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Montréal Quebec, H1T 1, Canada
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Montréal Quebec, H2X 0, Canada
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Rimouski Quebec, G5L 5, Canada
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Beijing , 10002, China
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Beijing , 10003, China
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Beijing , 10003, China
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Beijing , 10019, China
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Beijing , 10073, China
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Changsha , 43003, China
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Chengdu , 61000, China
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Chengdu , 61007, China
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Chongqing , 40004, China
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Dalian , 11601, China
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Fuzhou , 35000, China
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Guangzhou , 51008, China
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Guiyang , 55000, China
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Hangzhou , 31000, China
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Hangzhou , 31000, China
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Hangzhou , 31001, China
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Harbin , 15000, China
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Hefei , 23000, China
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Jinan , 25002, China
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Nanjing , 21002, China
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Shanghai , 20003, China
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Tianjin , 30022, China
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Wuhan , 43002, China
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Wuhan , 43003, China
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Xi'an , 71006, China
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Praha , 128 0, Czechia
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Aarhus , 8200, Denmark
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Copenhagen , DK-21, Denmark
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Odense C , 5000, Denmark
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Bron , 69677, France
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Chambray Les Tours , 37170, France
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Créteil Cédex , 94010, France
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Marseille , 13005, France
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Montpellier , 34295, France
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Paris Cedex 13 , 75651, France
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Paris , 75018, France
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Pessac , 33604, France
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Poitiers , 86021, France
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Rennes Cedex 9 , 35033, France
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Saint-Herblain , 44093, France
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Toulouse , 31059, France
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Bonn , 53127, Germany
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Cologne , 50937, Germany
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Essen , 45147, Germany
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Gießen , 35392, Germany
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Greifwald , 17489, Germany
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Göttingen , 37075, Germany
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Hamburg , 22767, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Homburg , 66421, Germany
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Kiel , 24105, Germany
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Leipzig , 04103, Germany
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München , 81377, Germany
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Münster , 48149, Germany
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Würzburg , 97078, Germany
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Würzburg , 97078, Germany
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Athens , 11528, Greece
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Athens , 11528, Greece
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Dublin , 7, Ireland
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Dublin , 8, Ireland
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Beer Yaakov , 70300, Israel
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Haifa , 31096, Israel
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Haifa , 34362, Israel
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Jerusalem , 91120, Israel
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Jerusalem , 93722, Israel
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Petah Tikva , 49414, Israel
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Rehovot , 76100, Israel
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Bologna , 40138, Italy
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Ferrara , 44124, Italy
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Florence , 50134, Italy
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Forli , 47121, Italy
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Messina , 98124, Italy
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Milano , 20122, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Pavia , 27100, Italy
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Pisa , 56124, Italy
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Roma , 00189, Italy
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Torino , 10154, Italy
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Trieste , 34128, Italy
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Bunkyo-ku , 113-8, Japan
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Kumamoto-shi , 860-8, Japan
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Kurume-shi , 830-0, Japan
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Kyoto-shi , 602-8, Japan
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Matsumoto-shi , 390-8, Japan
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Sapporo-shi , 060-8, Japan
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Shinjuku-ku , 160-8, Japan
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Suita-shi , 564-8, Japan
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Busan , 49241, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seoul , 5505, Korea, Republic of
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Wonju-si , 26426, Korea, Republic of
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Groningen , 9713 , Netherlands
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Maastricht , 6229, Netherlands
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Rotterdam , 3015 , Netherlands
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Utrecht , 3584, Netherlands
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Auckland , 2025, New Zealand
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Lørenskog , N-147, Norway
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Oslo , 0372, Norway
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Trondheim , 7030, Norway
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Gdansk , 80-95, Poland
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Krakow , 31-20, Poland
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Poznań , 61-84, Poland
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Warszawa , 02-09, Poland
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Warszawa , 04-62, Poland
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Barcelona , 8035, Spain
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El Palmar , 30120, Spain
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Jaen , 23007, Spain
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L'Hospitalet de Llobregat , 08907, Spain
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La Coruna , 15006, Spain
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Madrid , 28027, Spain
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Majadahonda , 28222, Spain
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Malaga , 29010, Spain
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Palma de Mallorca , 07198, Spain
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Pamplona , 31008, Spain
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Salamanca , 37007, Spain
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Santiago De Compostela-Coruña , 15706, Spain
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Valencia , 46010, Spain
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Göteborg , 41345, Sweden
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Lund , 221 8, Sweden
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Stockholm , 171 6, Sweden
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Basel , 4031, Switzerland
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Bern , 3010, Switzerland
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Luzern , 6000, Switzerland
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St.Gallen , 9007, Switzerland
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Zürich , 8006, Switzerland
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New Taipei City , 220, Taiwan
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Taichung , 404, Taiwan
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Taichung , 40705, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11220, Taiwan
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Ankara , 06230, Turkey
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Dinar , 03400, Turkey
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Eskisehir , 26480, Turkey
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Istanbul , 34180, Turkey
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Istanbul , 34303, Turkey
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Izmir , 35340, Turkey
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Mersin , 33079, Turkey
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Birmingham , B15 2, United Kingdom
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Cardiff , CF15 , United Kingdom
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Glasgow , G20 0, United Kingdom
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Hexham , NE46 , United Kingdom
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London , NW3 2, United Kingdom
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London , SE1 1, United Kingdom
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London , SW17 , United Kingdom
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Manchester , M15 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

1000

Study ID:

NCT06183931

Recruitment Status:

Recruiting

Sponsor:


Alexion Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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