EUCTR2017-001903-60-DE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
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
- •F.1.3.1 Number of subjects for this age range
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.
- •-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN).
- •-Creatinine phosphokinase (CPK) >3 x ULN.
研究者
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