Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 986
- 试验地点
- 177
- 主要终点
- Percentage of Participants Who Experienced Adverse Events (AEs)
研究概览
简要总结
Primary Objective:
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
- To evaluate the long-term efficacy of alirocumab on lipid parameters.
- To evaluate the long-term immunogenicity of alirocumab.
详细描述
The maximum study duration will be 176 weeks per participant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alirocumab 75 or 150 mg Q2W
Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.
干预措施: Alirocumab (Drug)
Alirocumab 75 or 150 mg Q2W
Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.
干预措施: Lipid-Modifying Therapy (LMT) (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Adverse Events (AEs)
时间窗: Up to 10 weeks after last study drug administration (maximum of 176 weeks)
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
次要结局
- Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168(Parent Baseline, Weeks 48, 96, 144, and 168)
- Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168(Parent Baseline, Weeks 48, 96, 144, and 168)
- Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168(Parent Baseline, Weeks 48, 96, 144, and 168)
- Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168(Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168)
- Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168(Parent Baseline, Weeks 48, 96, 144, and 168)