NCT04455581Unknown2 期
Open-label, Single-arm, Multicentre Study to Evaluate Efficacy and Safety of SHR-1209 in Subjects With Homozygous Familial Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 8
- 主要终点
- Percent Change from Baseline in LDL-C at Week 12
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint was percentage change in LDL cholesterol from baseline at week 12 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years of age
- •Diagnosis of homozygous familial hypercholesterolemia
- •Stable lipid-lowering therapies for at least 28 days
- •LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
- •Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- •Bodyweight of ≥ 40 kg at screening.
排除标准
- •LDL or plasma apheresis within 8 weeks prior to randomization
- •New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
- •Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, Planned cardiac surgery or revascularization, Uncontrolled cardiac arrhythmia
- •Liver transplant history.
- •Uncontrolled hypertension.
- •Moderate to severe renal dysfunction.
- •Active liver disease or hepatic dysfunction.
- •Known sensitivity to any of the products to be administered during dosing
研究组 & 干预措施
Treatment group
Experimental
SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral
干预措施: SHR-1209 (Drug)
结局指标
主要结局
Percent Change from Baseline in LDL-C at Week 12
时间窗: Week 12
次要结局
- Percent Change From Baseline in the Total Cholesterol at Week 12(Week 12)
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in HDL-C at Week 12(Week 12)
- Number of investigational product-related adverse events(Weeks 12 and 20)
- Change From Baseline in LDL-C at Week 12(Week 12)
- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in ApoB at Week 12(Week 12)
- Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in Lipo(a) at Week 12(Week 12)
- Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in Triglycerides at Week 12(Week 12)
- Percent Change From Baseline in Apo A1 at Week 12(Week 12)
- Number of ADA and Nab(Week 20)
- Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12(Weeks 10 and 12)
- Percent Change From Baseline in Non-HDL-C at Week 12(Week 12)
- Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12(Weeks 10 and 12)
研究者
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