EUCTR2015-003755-21-DE进行中（未招募）1 期
An Open-Label 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. Able and willing to participate in a 65-week study
- •2. Group 1 and 2: Satisfactory completion of ISIS 304801-CS6 or ISIS
- •CS16 (index studies) with an acceptable safety profile, per
- •Sponsor and Investigator judgment
- •3. Group 3: Patients who did not participate in the CS6 or CS16 index
- •studies and meet additional inclusion criteria of Familial
- •Chylomicronemia Syndrome (FCS) may enroll in the study.
- •3a: History of chylomicronemia
- •3b: A diagnosis of Familial Chylomicronemia Syndrome (Type 1
- •Hyperlipoproteinemia)
- •3c: Fasting triglycerides = 750 mg/dL (8.4 mmol/L) at
- •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
- •For Group 1 and Group 2:
- •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
- •For Group 3:
- •a. Diabetes mellitus if newly diagnosed or if HbA1c = 9.0%
- •b. Active pancreatitis within 4 weeks of screening
- •c. Acute Coronary Syndrome within 6 months of screening
- •d. Major surgery within 3 months of screening
- •e. Treatment with Glybera therapy within 2 years of screening
- •f. Have any other conditions in the opinion of the investigator which
- •could interfere with the patient participating in or completing the study.
研究者
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