A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM

Korábbi kezelés

• Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.
• Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM.

Más betegség

• Likely to undergo heart transplantation within a year of screening.
• Biomarkers of myocardial wall stress: NT-ProBNP ≥ 8,500 pg/mL.
• Measure of kidney function, estimated glomerular filtration rate by Modification of Diet in Renal Disease formula < 30 mL/minute/1.73 meters squared.

Laborértékek

• Current treatment with calcium channel blockers with conduction system effects (for example, verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed.

Egyéb

• Hemodynamic instability at screening.
• Confirmed diagnosis of light-chain (AL) amyloidosis.

• Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype.
• History of heart failure evidenced by at least 1 prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated pressures or heart failure symptoms that required or requires ongoing treatment with a diuretic.
• New York Heart Association Class I-III symptoms due to ATTR-CM.
• On stable doses of cardiovascular medical therapy.
• Completed ≥ 150 meters on the 6MWT on 2 tests prior to Day 1.
• Left ventricular (LV) wall (interventricular septum or LV posterior wall) thickness ≥ 12 millimeters.
• Biomarkers of myocardial wall stress: N-terminal pro-brain-type natriuretic pep (NT-proBNP) level ≥ 300 picograms/milliliter (pg/mL).