EUCTR2015-003755-21-NL进行中（未招募）1 期
An Open-Label Extension Study of Volanesorsen Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •1. Satisfactory completion of ISIS 304801-CS6 or ISIS 304801-CS16 (index studies) with an acceptable safety profile
- •2. History of chylomicronemia
- •3. A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
- •4. Fasting triglycerides = 750 mg/dL (8.4 mmol/L) at Screening for the index studies
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study;
- •2. Unwilling to comply with lifestyle requirements for the duration of the study.
研究者
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