JPRN-jRCT2031210402进行中（未招募）3 期
HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)
Yamaji Hideomi0 个研究点目标入组 24 人开始时间: 2021年10月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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.
研究者
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