NL-OMON43236已完成2 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 - Safety/efficacy study in patients with Hereditary high cholesterol
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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;
- •Please refer to the Protocl for a full list of Inclusion criteria.
排除标准
- •1. Background medical lipid modifying therapy that has not been stable for at leat 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
- •Please refer to the Protocl for a full list of Exclusion criteria.
研究者
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