NCT03409744已完成3 期
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 5
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216
研究概览
简要总结
The primary objectives of the study are:
- To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH)
- To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH
The secondary objectives of the study are:
- To evaluate the effect of evinacumab on lipid parameters in patients with HoFH
- To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH
- To evaluate the potential development of anti-evinacumab antibodies
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the parent study in which they participated
- •Able to understand and complete study-related questionnaires
排除标准
- •Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient
- •Concomitant medications that have not been stable prior to the baseline visit
- •Adverse event leading to permanent discontinuation from parent study
- •Any new condition or worsening of an 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
- •Member of the clinical site study team and/or his/her immediate family
- •Pregnant or breastfeeding women
- •Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug
- •Men who are sexually active with women of childbearing potential and are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug: vasectomy with medical assessment of surgical success OR consistent use of a condom.
- •Note: Other protocol defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
evinacumab
Experimental
干预措施: evinacumab (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216
时间窗: Up to 216 weeks
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
次要结局
- Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time(Up to 120 weeks)
- Absolute Change in Non-HDL-C Over Time(Up to 120 weeks)
- Absolute Change in LDL-C Over Time(Up to 120 weeks)
- Percent Change in Triglycerides (TGs) Over Time(Up to 120 weeks)
- Percent Change in Apolipoprotein B (Apo B) Over Time(Up to 120 weeks)
- Percent Change in Total Cholesterol (TC) Over Time(Up to 120 weeks)
- Absolute Change in Apo B Over Time(Up to 120 weeks)
- Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time(Up to 120 weeks)
- Absolute Change in TC Over Time(Up to 120 weeks)
- Absolute Change in TGs Over Time(Up to 120 weeks)
研究者
研究点 (5)
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