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.
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 to 90
Critères de participation
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
Lieu de l'étude
Research Site
Research SiteCalgary, Alberta
Canada
Contactez l'équipe d'étude
Research Site
Research SiteToronto, Ontario
Canada
Contactez l'équipe d'étude
Research Site
Research SiteRimouski, Quebec
Canada
Contactez l'équipe d'étude
Research Site
Research SiteLondon, Ontario
Canada
Contactez l'équipe d'étude
Research Site
Research SiteMontréal, Quebec
Canada
Contactez l'équipe d'étude
Research Site
Research SiteVancouver, British Columbia
Canada
Contactez l'équipe d'étude
Research Site
Research SiteChicoutimi, Quebec
Canada
Contactez l'équipe d'étude
Research Site
Research SiteWinnipeg, Manitoba
Canada
Contactez l'équipe d'étude
Research Site
Research SiteMontréal, Quebec
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Alexion Pharmaceuticals, Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06183931