EUCTR2011-005399-40-NL进行中（未招募）不适用
A two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 59
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
- •Subject has provided informed consent.
- •Male or female = 12 to = 80 years of age
- •Diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL cholesterol concentration greater than 500 mg/dl (13 mmol/L) together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents.
- •On a stable on a low-fat diet and taking pre-existing lipid-lowering therapies (such as statins, cholesterol-absorption inhibitors, bile-acid sequestrants or nicotinic acid, or combinations thereof) for at least 4 weeks, with fasting central lab LDL cholesterol concentration > 130 (3.4 mmol/L)
- •Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening
- •Bodyweight of 40 kg or greater at screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •LDL or plasma apheresis within 8 weeks prior to enrollment
- •Use of Mipomersen or Lomitapide within 5 months of screening
- •NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%
- •Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to enrollment
- •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to enrollment
- •Planned cardiac surgery or revascularization within 20 weeks of screening
- •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg, confirmed with repeat measurement
- •Subject requires uptitration of their current statin dose within 4 weeks of screening (these subjects can be uptitrated and rescreened 1 month later)
- •Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN as determined by central laboratory analysis at screening
- •Unexplained CK > 5 times the ULN at screening, confirmed by a repeat measurement at least 1 week apart
- •Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
- •Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment
- •Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
- •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- •Female subject of childbearing potential who is not willing to inform
- •her sexual partner of her participation in this clinical study and who
- •is not willing to use an acceptable method(s) of birth control during
- •treatment with Investigational product (AMG 145 or placebo) and for
- •an additional 15 weeks after the last dose of Investigational Product
- •(AMG 145 or placebo) unless subject is sterilized or postmenopausal.
- •Male subject with a female partner of childbearing potential not wiling to agree to inform his partner of his participation in this clinical study.
- •Subject is pregnant or breast feeding, planning to become pregnant or planning to breastfeed during treatment with Investigational Product (AMG 145 or placebo) and/or within 15 weeks after the last dose of Investigational Product (AMG 145 or placebo).
- •Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years
- •Subject has previously received AMG 145 or any other investigational therapy to inhibit inhibiting PCSK9
- •Known sensitivity to any of the products to be administered during dosing
- •Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator’s knowledge.
- •Subject has any kind of disorder that, in th
研究者
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