Helios-B: A Phase 3, Randomized, Doubleblind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy) - HELIOS-B

Alnylam Pharmaceuticals, Inc.0 个研究点目标入组 600 人开始时间: 2022年5月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. 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.
•2. Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF.

•1. Has known primary amyloidosis or leptomeningeal amyloidosis
•2. Has New York Heart Association (NYHA) Class IV heart failure
•3. Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria
•4. Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit
•5. Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2
•6. Has received prior TTR-lowering treatment
•7. Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to
•ischemic heart disease

发起方