EUCTR2021-002192-19-PT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 540
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
- 性别
- All
入选标准
- •- Fasting TG = 500 mg/dL (5.65 mmol/L) at Screening and Qualification
- •- Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.
- •Other protocol defined criteria will apply.
- •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 490
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Hemoglobin A1c (HbA1c) = 9.5% at Screening
- •Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
- •Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
- •Estimated GFR < 30 mL/min/1.73 m^2
- •Other Protocol defined exclusion criteria will apply.
研究者
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