EUCTR2011-002539-24-DE进行中（未招募）1 期
Effect of Mipomersen on LDL-Cholesterol Levels in Patients with Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis - MICA
Hospital of the University of Munich0 个研究点目标入组 17 人开始时间: 2012年2月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 17
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
- •1.The patient is a male or female, age >/= 18 years.
- •2.The patient fulfils German criteria for regular LDL-apheresis:
- •a.Established atherosclerosis,
- •b.LDL-cholesterol >/=130 mg/dl despite maximal possible drug therapy.
- •3.Regular (weekly) LDL-apheresis >/= 3 months; no change in aphere-sis system for 6 weeks.
- •4.The patient has fasting pre-apheresis LDL-C >/= 130 mg/dL at screening.
- •5.The patient is receiving a stable, maximally tolerated, lipid-lowering regimen, and is expected to remain on this regimen through the end of treatment, including both:
- •a.A maximally tolerated statin treatment greater than zero, unless the patient has a documented history of statin intoler-ance, stable for at least 12 weeks prior to screening.
- •b.A stable low-fat diet (e.g. NCEP-ATP III therapeutic lowering cholesterol or equivalent).
- •c.Note: Patients may receive another class of lipid-lowering therapy (e.g. cholesterol absorption inhibitors, bile-acid se-questrants, fibrates, niacin, fish oil), as long as it (drug and dose) has been stable for at least 6 weeks prior to screening
- •6.The patient has a body mass index (BMI) 6 weeks prior to screening.
- •7.The patient satisfies one of the following criteria:
- •a.Females: Non-pregnant and non-lactating; either surgically sterile, post-menopausal (e.g. one year without menstrual pe-riods), or patient or partner compliant with an acceptable and highly effective contraceptive regimen (a regimen which results in a failure rate of less than 1% per year) for 4 weeks prior to screening, and willing to remain compliant during and for 24 weeks after the last investigational product dose.
- •b.Males: Either surgically sterile or patient or partner is willing to utilize an acceptable and highly effective contraceptive method during and for 24 weeks after the last investigational product dose.
- •8.Patients with the ability to follow study instructions and likely to attend and complete all required visits.
- •9.Written informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.The patient has experienced MI, percutaneous transluminal coronary intervention (PTCI), CABG, cerebrovascular accident, unstable angina, or acute coronary syndrome within 12 weeks of screening.
- •2.The patient has a clinically significant arrhythmia that was deemed to be uncontrolled at any time < 3 months before screening or medication for an arrhythmia was started or dose was changed < 3 months before screening. Patients with implantable pacemakers or automatic implantable cardioverter defibrillators (AICDs) may be considered if deemed to be stable for the previous 3 months by the Investigator.
- •3.The patient has insulin-dependent diabetes mellitus (Type 1), or if Type 2 diabetes, HbA1c > 8% at screening.
- •4.The patient has New York Heart Association (NYHA) functional clas-sification III or IV heart failure.
- •5.The patient has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg at screening (despite antihypertensive medication/therapy).
- •6.The patient has an active infection requiring systemic antiviral or an-timicrobial therapy unless treatment expected to be completed by day 1.
- •7.The patient has a positive test for HIV or hepatitis B or C at screen-ing.
- •8.The patient has any uncontrolled condition that may predispose to secondary hyperlipidemia such as uncontrolled hypothyroidism.
- •9.The patient has had a malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated.
- •10.The patient has clinically significant hepatic (e.g. History of confirmed non-alcoholic steatosis hepatis NASH) or renal disease or Gilbert’s syndrome.
- •11.The patient has previously received mipomersen treatment.
- •12.The patient has any of the following laboratory values at screening:
- •a.Serum creatine phosphokinase (CPK) > 3 x upper limit of nor-mal (ULN),
- •b.Alanine aminotransferase (ALT) levels > 1.5 x ULN,
- •c.Serum creatinine > 0.1 mg/dL (> 8.8 µmol/L) above ULN for women, or > 0.2 mg/dL (> 17.7 µmol/L) above ULN for men,
- •d.Proteinuria (> 1000 mg protein / g creatinine on spot urine),
- •e.Total bilirubin > 1.2 x ULN,
- •f.The patient has a fasting TG value >350 mg/dL (3.95 mmol/L).
- •13.The patient has used any of the following medications within 12 weeks of Screening:
- •a.Cholestin™ (also known as red yeast rice, or monascus pur-pureus extract),
- •b.Anti-obesity medication,
- •c.Chronic systemic corticosteroids or anabolic agents except for replacement therapy.
- •14.The patient is currently using any of the following medications - unless a stable dose regimen was used for at least 12 weeks prior to screening and the dose and regimen are expected to remain stable un-til the end of treatment:
- •a.Oral anticoagulants (e.g., warfarin; minimal dose adjustments considered to be within usual limits for the patient are allowed per Investigator judgment),
- •b.Hormone replacement therapy,
- •c.Diabetes medications including - but not limited to - sulfony-lureas, metformin and glitazones, with the exception of changes of ± 10 units of insulin,
- •d.Prophylactic antiviral therapy for herpes simplex virus (HSV),
- •e.Oral contraceptives (with the exception of progestagen-only pills), combined injectable contraceptives, and combined con-traceptive rings or patches.
- •15.The patient has received treatment with another investigational drug, biological agent, or device within 4 weeks of screening or 5 half-lives of the study agent, whichever is longer.
- •16.The patient has a current or a recent history of d
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