2024-519917-72-00招募中3 期
TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)
Alnylam Pharmaceuticals Inc.96 个研究点 分布在 6 个国家目标入组 676 人开始时间: 2025年10月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 676
- 试验地点
- 96
- 主要终点
- Composite outcome of all-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits)
研究概览
简要总结
Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and CV events
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18 (or age of legal consent per local regulations, whichever is older) to 85 years, inclusive.
- •Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy:
- •Medical history of HF with at least 1 prior hospitalization for HF OR clinical evidence of HF (with or without hospitalization)
- •Patients may be receiving approved TTR stabilizers for ATTR amyloidosis and may be receiving background therapy for HF but must be stable for at least 30 days prior to screening
- •Patient is clinically stable, with no CV-related hospitalizations within 6 weeks prior to randomization
- •Screening NT-proBNP >300 ng/L and <8500 ng/L; in patients with permanent or persistent atrial fibrillation, Screening NT-proBNP >600 ng/L and <8500 ng/L
- •Patient is able to understand and is willing and able to comply with the study requirements and to provide written informed consent
排除标准
- •Has known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
- •Female patient is pregnant, planning a pregnancy, or breastfeeding
- •Unwilling or unable to limit alcohol consumption, with a history of alcohol use disorder within the last 12 months, or a history of illicit drug use within the past 5 years that could interfere with study compliance
- •NYHA Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3 (defined as NT-proBNP >3000 ng/L and eGFR <45 mL/min)
- •Has a polyneuropathy disability Score IIIa, IIIb, or IV at the Screening visit.
- •Has any of the following lab parameter at screening: a. AST or ALT levels ˃2.0×ULN; b. Total bilirubin >2.0×ULN; c. INR >1.5 (unless patients were on anticoagulant therapy in which case excluded if INR ˃3.5).
- •Has an eGFR of <30 mL/min/1.73m2 at screening (calculation will be based on the CKD-EPI equation)
- •Has known HIV infection or evidence of current or chronic HCV or HBV infection.
- •Patients with current, prior or planning to receive TTR-lowering therapy, anti-TTR antibody treatment, diflunisal, or participating in another investigational study (must meet washout periods of previous treatment to be included).
- •Patients with the following medical conditions: • significant non-TTR cardiomyopathies, unstable CHF, recent acute coronary syndrome, ventricular arrhythmias, pacemaker-indicated nodal dysfunction, or uncontrolled high blood pressure are excluded from the study. • untreated hypo- or hyperthyroidism • active infections requiring systemic antiviral, antiparasitic, or antimicrobial therapy that will not be completed before dosing • Prior or anticipated ( 12 months after randomization) organ transplant or implantation of LVAD • multiple drug allergies or history of allergic reaction to any component of study drug • intolerance to SC injection • other medical conditions or comorbidities that could interfere with study compliance or data interpretation, or a life expectancy of <2 years due to any non-cardiovascular condition
- •Unwilling to comply with the contraceptive requirements during the study;
结局指标
主要结局
Composite outcome of all-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits)
Composite outcome of all-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits)
次要结局
- •Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality •All-cause mortality •Recurrent CV events •Change from baseline in KCCQ-OS
研究者
Alnylam Clincial Trial Information Line
Scientific
Alnylam Pharmaceuticals Inc.
研究点 (96)
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