A Study to Evaluate Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy

Prior treatment

• Permanently discontinued study drug administration while participating in the parent studies, Study ALN-TTR02-011, Study ALN-TTR02-014, or Study ALN-TTRSC02-003.
• Future or current participation in another investigational device or drug study, scheduled to occur during this study.

Other illness

• Has other medical conditions or comorbidities (eg, malignancy, neuropsychiatric disorder) which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.

Lab values

• Requires treatment with or is unwilling to avoid any concurrent treatment with non-dihydropyridine calcium channel blockers (eg, verapamil, diltiazem).

Other

• Is not willing to comply with the contraceptive requirements during the study period.
• Female patient is pregnant, planning a pregnancy, or breast-feeding.
• Unwilling or unable to limit alcohol consumption throughout the course of the study. Alcohol intake of >2 units/day is excluded during the study (unit: 1 glass of wine [approximately 125 mL] = 1 measure of spirits [approximately 1 fluid ounce] = ½ pint of beer [approximately 284 mL]).

• Patients with ATTR amyloidosis (hereditary or wt) who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003.
• Willingness to adhere to vitamin A supplementation per protocol.
• Patient or legal guardian, where relevant and allowable by law, is able to understand and is willing and able to comply with the study requirements and to provide written informed consent.