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Active (not recruiting) Phase 3 NCT06183931

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

Phase 3 – large-scale trial before approval
Conditions: Transthyretin Amyloid Cardiomyopathy

Sponsor: Alexion Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
The 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.
Who can participate
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
Locations 24
Argentina (1)
Research Site
Buenos Aires
Australia (1)
Research Site
Bedford Park
Belgium (1)
Research Site
Bruges
Brazil (1)
Research Site
Aracaju
Canada (1)
Research Site
Calgary , Alberta
China (1)
Research Site
Beijing
Czech Republic (1)
Research Site
Prague
Denmark (1)
Research Site
Aarhus
France (1)
Research Site
Bron
Greece (1)
Research Site
Athens
Ireland (1)
Research Site
Dublin
Israel (1)
Research Site
Beer Yaakov
Italy (1)
Research Site
Bologna
Japan (1)
Research Site
Bunkyō City
Netherlands (1)
Research Site
Groningen
Norway (1)
Research Site
Lørenskog
Poland (1)
Research Site
Gdansk
South Korea (1)
Research Site
Busan
Spain (1)
Research Site
A Coruña
Sweden (1)
Research Site
Gothenburg
Taiwan (1)
Research Site
New Taipei City
Turkey (1)
Research Site
Ankara
United Kingdom (1)
Research Site
Birmingham
United States (1)
Research Site
Irvine , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
11.01.2024
Completion date
05.10.2027
Registry ID
NCT06183931
Source
anzctr
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