Patients with ATTR amyloidosis (hATTR or wtATTR) with cardiomyopathy
Conditions
Interventions
Participants will receive vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) during the double-blind period.
Drug: Vutrisiran
Vutrisiran 25 mg will be administered by SC injec
Sponsors
Ito Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria - Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF
Exclusion criteria
Exclusion criteria: - Has known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis. - Has NYHA Class IV heart failureNYHA Class IV heart failure. - Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria. - Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit. - Has eGFR <30 mL/min/1.73 m2. - Has received prior TTR-lowering treatment. - Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Endpoint of all-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) | — |
Countries
Canada, France, Germany, Japan, Korea, Mexico, USA
Contacts
Public ContactHiroshi Ito
PPDSNBL K.K
Outcome results
None listed