JPRN-jRCT2080224038已完成Unknown
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EVINACUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
Regeneron Pharmaceuticals, Inc.(ICCC: PAREXEL International)0 个研究点目标入组 65 人开始时间: 2018年8月20日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
In patients with homozygous familial hypercholesterolemia receiving maximum doses of lipid-lowering therapy, the reduction from baseline in the LDL cholesterol level in the evinacumab group, as compared with the small increase in the placebo group, resulted in a between-group difference of 49.0 percentage points at 24 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Diagnosis of functional HoFH
- •2. If undergoing LDL apheresis, must have initiated LDL apheresis at least 3 months prior
- •to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks
排除标准
- •1.LDL-C level <70 mg/dL (1.81 mmol/L) at the screening visit
- •2.Background medical Lipid Modifying Therapy (LMT) (if applicable) that has not been stable before the screening visit
- •3.Lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit
- •4.Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit
- •5.Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
- •6.Newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (HbA1c >9%) diabetes
- •7.History of a MI, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit
- •8.Pregnant or breastfeeding women
- •9.Sexually active women of child bearing potential (WOCBP), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug
- •10.Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last dose of study drug
- •Note: Other protocol defined inclusion/exclusion criteria may apply.
研究者
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