NCT01588496已完成2 期
2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 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
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).
详细描述
Study Masking:
Part A: Open Label Part B: Double Blind
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 12 to ≤ 80 years of age
- •Diagnosis of homozygous familial hypercholesterolemia
- •Stable lipid-lowering therapies for at least 4 weeks
- •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 (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
- •Planned cardiac surgery or revascularization
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
研究组 & 干预措施
Part B: Placebo
Placebo Comparator
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
干预措施: Placebo (Drug)
Part A: Evolocumab
Experimental
Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
干预措施: Evolocumab (Biological)
Part B: Evolocumab
Experimental
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
干预措施: Evolocumab (Biological)
结局指标
主要结局
Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
LDL-C was quantified using the ultracentrifugation method.
Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
LDL-C was quantified using the ultracentrifugation method.
次要结局
- Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12(Baseline and Weeks 6 and 12)
- Part A: Change From Baseline in LDL-C at Week 12(Baseline and Week 12)
- Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12(Baseline and Weeks 6 and 12)
- Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12(Baseline and Week 12)
- Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12(Baseline and Week 12)
- Part A: Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
- Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12(Baseline and Week 12)
- Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12(Baseline and Week 12)
- Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12(Baseline and Week 12)
- Part B: Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
- Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12(Baseline and Week 12)
- Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12(Baseline and Weeks 6 and 12)
研究者
研究点 (1)
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