EUCTR2013-002856-33-GB进行中（未招募）不适用
A Phase 2, Open-Label Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Exploratory Clinical Activity of ALN-TTRSC in Patients with Transthyretin (TTR) Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females 18 to 80 years of age, inclusive;
- •Biopsy-proven TTR cardiac amyloidosis
- •NYHA Class =3
- •Stable congestive heart failure status and stable clinical treatment
- •Able to walk =150 meters
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Uncontrolled hypertension;
- •Uncontrolled ischemic heart disease;
- •Uncontrolled clinically significant cardiac arrhythmia;
- •Untreated hypo- or hyperthyroidism
- •Prior major organ transplant;
- •Known or suspected systemic bacterial, viral, parasitic, or fungal infection;
- •Seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV) or known to be human immunodeficiency virus (HIV) positive;
- •Received an investigational agent other than tafamidis, diflunisal, doxycycline or tauroursodeoxycholic acid, or an investigational device within 30 days prior to first dose of study drug;
研究者
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