Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid CardiomyopathyThe primary objective of this study is to access 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 total occurrences of all-cause mortality (ACM) and cardiovascular (CV) clinical events.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 90
Participation Criteria
Inclusion Criteria:
* Diagnosis of ATTR-CM with either wild-type or variant TTR genotype
* End-diastolic interventricular septal wall thickness ≥ 12 mm 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 Location
Research Site
Research SiteCalgary, Alberta
Canada
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Research Site
Research SiteToronto, Ontario
Canada
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Research Site
Research SiteRimouski, Quebec
Canada
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Research Site
Research SiteLondon, Ontario
Canada
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Research Site
Research SiteMontréal, Quebec
Canada
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Research Site
Research SiteVancouver, British Columbia
Canada
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Research Site
Research SiteChicoutimi, Quebec
Canada
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Research Site
Research SiteWinnipeg, Manitoba
Canada
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Research Site
Research SiteMontréal, Quebec
Canada
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- Study Sponsored By
- Alexion Pharmaceuticals, Inc.
- Participants Required
- More Information
- Study ID:
NCT06183931