NL-OMON40135已完成2 期
A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - 20110271
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 23
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
- •Males and females, >= 12 to <= 80 years of age diagnosed with severe familial
- •hypercholesterolemia must meet the following criteria in order to participate in this study:
- •OR: Completed study 20110233 or a qualifying AMG 145 parent protocol, did not experience
- •a treatment related serious adverse event that led to IP discontinuation, and are still
- •taking investigational product at the end of that study.
- •OR: Subjects that have not participated in a qualifying AMG 145 parent protocol must
- •also meet all of the following inclusion criteria:
- •- Are on a stable low-fat diet and taking pre-existing lipid-lowering therapies
- •- Fasting triglycerides <= 400 mg/dL (4.5 mmol/L)
排除标准
- •use of Mipomersen or Lomitapide within 5 months of screening; New York Heart Failure
- •Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%; cardiac
- •arrhythmia within past 3 months that is not controlled by medication; myocardial infarction,
- •unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
- •or stroke within 3 months of enrollment; planned cardiac surgery or revascularization; systolic
- •blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg; requiring statin
- •up-titration within 4 weeks of screening; estimated glomerular filtration rate (eGFR) <
- •30 ml/min/1.73m2; persistent aspartate aminotransferase (AST) or alanine aminotransferase
- •(ALT) > 3x ULN, creatine kinase (CK) > 5x ULN without a known cause; known major active
- •infection, use of CETP inhibitor in the last 12 months prior to LDL-C screening
研究者
相似试验
进行中（未招募）
1 期
A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDHomozygous Familial HypercholesterolemiaEUCTR2011-005400-15-ITAmgen Inc300
进行中（未招募）
不适用
A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutationsMedDRA version: 14.1Level: LLTClassification code 10057100Term: Homozygous familial hypercholesterolaemiaSystem Organ Class: 100000004850Homozygous Familial HypercholesterolemiaEUCTR2011-005400-15-ATAmgen Inc125
进行中（未招募）
1 期
A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutationsMedDRA version: 19.0 Level: LLT Classification code 10057100 Term: Homozygous familial hypercholesterolaemia System Organ Class: 100000004850Familial HypercholesterolemiaEUCTR2011-005400-15-GBAmgen Inc300
进行中（未招募）
1 期
A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutationsMedDRA version: 18.0Level: LLTClassification code 10057100Term: Homozygous familial hypercholesterolaemiaSystem Organ Class: 100000004850Familial HypercholesterolemiaEUCTR2011-005400-15-NLAmgen Inc300
进行中（未招募）
1 期
A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutationsMedDRA version: 20.0Level: LLTClassification code 10057100Term: Homozygous familial hypercholesterolaemiaSystem Organ Class: 100000012386Familial HypercholesterolemiaEUCTR2011-005400-15-BEAmgen Inc300