EUCTR2012-001831-30-PT进行中（未招募）1 期
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
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
- •Diagnosed Stage 1 or Stage 2 FAP patient
- •Meets NIS requirements
- •Male or female aged 18 to 82 years old at the time of informed consent
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •Has inadequate liver, renal or heart function
- •Has retinol levels at screen < LLN
- •Has human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- •Has type 1 or type 2 diabetes mellitus or other cause of sensorimotor or autonomic neuropathy
- •Recently treated with another investigational drug, biological agent or device
- •Is currently taking Vyndaqel® or diflunisal
- •Prior liver transplant or anticipated liver transplant within 1 year of screening
- •Anticipated survival less than 2 years
研究者
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