EUCTR2016-000411-32-NL进行中（未招募）1 期
AN OPEN-LABEL, SINGLE-ARM, PROOF-OF-CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE AND MULTIPLE DOSES OF REGN1500 IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women =18 years of age at the time of the screening visit
- •2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)
- •3. Willing to consistently maintain usual diet for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit
- •2. Having undergone lipid apheresis within 4 weeks prior to the screening visit
- •3. Use of another investigational drug or therapy within 30 days or at least 5 half lives (whichever is longer) prior to the screening visit
- •4. Previous participation in any clinical trial of REGN1500
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