CTIS2023-507220-23-00进行中（未招募）1 期
MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM). - ITL-2001-CL-301
Intellia Therapeutics Inc.0 个研究点目标入组 1,086 人开始时间: 2024年1月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,086
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
- •1. 18 to 90 years of age., 2. Male or Female., 3. Documented diagnosis of ATTR amyloidosis with cardiomyopathy, 4. Medical history of heart failure (HF), 5. Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention, 6. Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 1000 pg/mL (or greater than or equal to 2000 pg/mL if participant has known atrial fibrillation)
排除标准
- •1. New York Heart Association (NYHA) Class IV HF, 10. Unable or unwilling to take vitamin A supplementation for the duration of the study., 2. Polyneuropathy Disability score of IV (confined to wheelchair or bed), 3. Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection, 4. History of active malignancy within 3 years prior to screening, 5. RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed, 6. Initiation of tafamidis within 6 months prior to study dosing, 7. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2, 8. Liver failure, 9. Uncontrolled blood pressure
研究者
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