EUCTR2017-001903-60-DK
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Hypercholesterolaemia
- 发起方
- Sanofi-aventis recherche & développement
- 入组人数
- 500
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\-Children and adolescent male and female patients aged 8 to 17 years at the time of signed informed consent.
- •\-Patients with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.
- •\-Patients treated with optimal dose of statin \+/\- other LMT(s) or non\-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
- •\-Patients with calculated LDL\-C greater than or equal to 130 mg/dL (\=3\.37 mmol/L) at the screening visit except for patients who have previously participated in the DFI14223 study.
- •\-A signed informed consent indicating parental permission with or without patient assent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
排除标准
- •\-Patient with body weight less than 25 kg.
- •\-Patients aged of 8 to 9 years not at Tanner stage 1 and patients aged of 10 to 17 years not at least at Tanner stage 2 in their development.
- •\-Patients with secondary hyperlipidemia.
- •\-Diagnosis of homozygous familial hypercholesterolemia.
- •\-Patient who has received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
- •\-Patients with uncontrolled type 1 or type 2 diabetes mellitus.
- •\-Patients with known uncontrolled thyroid disease.
- •\-Patients with uncontrolled hypertension.
- •\-Fasting triglycerides \>350 mg/dL (3\.95 mmol/L).
- •\-Severe renal impairment (ie, estimated glomerular filtration rate \[eGFR] \<30 mL/min/1\.73 m^2\.
结局指标
主要结局
未指定
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