CTIS2023-506669-70-00招募中1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) - ALXN2220-ATTRCM-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 982
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female = 18 years to = 90 years of age at time of randomization., If treated with locally approved TTR gene silencing agent for ATTR amyloidosis (except as listed in Section 6.9.2 of the protocol), must be on a stable dose for at least 90 calendar days prior to Screening, Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement). Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participant is eligible to participate if she is not pregnant or breastfeeding, and is a woman of nonchildbearing potential or is a WOCBP and using a highly effective contraceptive method, and agrees not to donate eggs. Male participants are eligible to participate if they agree to refrain from donating fresh unwashed semen plus abstinent from heterosexual intercourse or must agree to use contraception/barrier,, Centrally confirmed diagnosis of ATTR-CM with either wild-type or a variant TTR genotype based on: Evidence of cardiac amyloidosis by echocardiography or cMRI and one of the following a. Endomyocardial biopsy with confirmatory TTR amyloid typing by either immunohistochemistry or mass spectrometry; OR b. Grade 2 or 3 cardiac uptake on 99mTc scintigraphy (99mTc DPD, 99mTc PYP, or 99mTc HMDP) in the absence of monoclonal gammopathy; OR c. Grade 2 or 3 cardiac uptake on 99mTc scintigraphy (99mTc DPD, 99mTc PYP, or 99mTc HMDP) AND confirmatory TTR amyloid typing by either immunohistochemistry or mass spectrometry in non-cardiac tissue in the presence of monoclonal gammopathy, End-diastolic interventricular septal wall thickness = 12 mm on echocardiography measured at Screening, NT-proBNP > 2000 pg/mL measured by a central laboratory at Screening, Treatment with a loop diuretic for at least 30 days prior to Screening, History of heart failure as documented by one of the following events within 1 year prior to Screening: a.heart failure hospitalization b.urgent heart failure visit c.episode of volume overload documented by NT-proBNP > 2000 pg/mL (or equivalent BNP), NYHA Class II-IV at Screening, Life expectancy of = 6 months as per the Investigator’s judgment
排除标准
- •Known leptomeningeal amyloidosis, Participants with renal failure requiring dialysis or who have an eGFR by CKD-Epi formula < 20 mL/min/1.73 m2 measured by a central laboratory at Screening, Polyneuropathy requiring a wheelchair, Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis, Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening, Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment., LVEF < 30% on echocardiography
研究者
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