EUCTR2020-004390-44-ES进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Heterozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-HeFH) - LIBerate-HeFH
IB Therapeutics, LLC0 个研究点目标入组 600 人开始时间: 2021年6月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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. Provision of written and signed informed consent prior to any study-specific procedure;
- •2. Male or female, =18 years of age at the first Screening Visit;
- •3. Weight of =40 kg (88 lbs) and body mass index (BMI) =17 and =42 kg/m2;
- •4. Diagnosis of definite, probable or possible HeFH based either on clinical criteria (Simon Broome register criteria or Dutch Lipid Clinic [DLC] Network Criteria or genotyping and at the defined eligibility visit (screening or post washout/stabilization) a calculated LDL-C (Friedewald) =70 mg/dL (if very-high risk for CVD) or =100 mg/dL (if high risk for CVD) and TG =400 mg/dL while on stable lipid lowering oral drug therapy (eg, maximally tolerated statin with or without ezetimibe);
- •Note: ASCVD encompasses acute coronary syndrome, history of myocardial infarction (MI), stable or unstable angina or coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease, including aortic aneurysm, all of atherosclerotic origin.
- •5. Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, and unable to tolerate any other allowed oral lipid lowering agent, and thus on no lipid lowering therapy must have an LDL-C =190 mg/dL (4.9 mmol/L) at the Screening Visit unless they have a documented pathogenic FH variant;
- •Note: Patients unable to tolerate approved doses of a statin may take lower than approved doses and less frequently than daily as long as the dose and dosing frequency is consistent. Patients with documented intolerance to statins may also participate.
- •6. On a stable diet23 and lipid-lowering oral therapies (statins, ezetimibe, bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid and bempedoic acid) or combinations thereof for at least 4 weeks (excluded oral lipid lowering agents are defined below in Section 4.2 and include mipomersen, lomitapide, and gemfibrozil);
- •7. Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of =4 weeks after the last dose; for those on a dose of 300 mg or 420 mg Q4W (=31 days) the washout period is =8 weeks following last dose. For patients who have received an siRNA PCSK9 inhibitor the washout period is =360 days post last dose;
- •8. Females of childbearing potential must be using a highly effective form of contraception if sexually active and have negative urine pregnancy test at the last Screening Visit;
- •Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, condom or diaphragm or cervical cap with spermicide or IUD, oral, implantable, or injectable contraceptives. Menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female ?55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle- stimulating hormone (FSH) level >40 IU/L (or according to the definition of postmenopausal range” for the laboratory involved) in a female <55 years old unless the patient has undergone bilateral oophorectomy.
- •9. Male patients will either be surgically sterile or agree to use the following forms of contraception: male or female condom with spermicide and a female partner who is sterile or who agrees to use the following contraceptives; diaphragm or cervical cap with spermicide; or intra
排除标准
- •1. Use of prohibited oral lipid lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of the Screening Visit;
- •2. Low-density lipoprotein or plasma apheresis within 2 months prior to Day 1;
- •3. Documented history of homozygous familial hypercholesterolemia defined as clinical and/or genetic with true HoFH (ie, identical pathogenic variants), compound heterozygous (ie, 2 different pathogenic LDLR variants) or combined heterozygous (2 different pathogenic FH variants such as LDLR plus Apo B, LDLR plus PCSK9 GOF);
- •4. History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, including but not limited to clinically significant pulmonary, hematologic, gastrointestinal, endocrine (excluding diabetes), immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator’s opinion would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;
- •5. Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;
- •Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, IUDs, sexual activity with a male partner who has had a vasectomy, condom or diaphragm or cervical cap with spermicide or IUD, oral, implantable, or injectable contraceptives.
- •6. Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate <30 mL/min/1.73m2 at the Screening Visit;
- •7. Active liver disease or hepatic dysfunction (eg, cirrhosis, alcoholic liver disease, known hepatitis B [HBV]or hepatitis C [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, and/or AST or ALT >2.5 × the ULN as determined by central laboratory analysis at screening (tests that result in ALT or AST up to 3 × ULN may have 1 repeat test to confirm eligibility during the Screening Period);
- •8. Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal (LLN) or >1.5 × ULN, respectively, at the Screening Visit. If TSH is above/below these cut-off points, the subject can enter if the free T3 is within the reference range. If controlled, then treatment should be stable for at least 3 months prior to the Screening Visit;
- •9. Uncontrolled Type 1 or Type 2 diabetes mellitus (defined as fasting glucose=200 mg/dL or glycated hemoglobin (HbA1c) of =9%);
- •10. Uncontrolled serious cardiac arrhythmia (sustained ventricular tachycardia, frequent non-sustained ventricular tachycardia, any ventricular fibrillation episode, wide-complex tachycardia, atrial fibrillation with rapid ventricular response, and severe second degree or third degree atrioventricular block), MI, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, placement of implantable cardioverter defibrillator or biventricular pacemaker, aortic valve surgery, or stroke within 3 months prior to enrollment (the day patient signs the informed consent and first procedure is performed);
- •11. Planned cardiac surgery or revascularization;
- •12. New York Heart Association III-IV heart failure; or patie
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