EUCTR2016-003307-62-GB进行中（未招募）1 期
A Phase 2, Randomized, Placebo-Controlled Study of Safety and Efficacy, Following Repeat-Dose Administration of Evinacumab (anti-ANGPTL3) in Patients with Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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. Males and females =18 to 75 years of age at screening
- •2. Previous documentation in the patient’s medical records of a fasting serum TG measurement = 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG values >500 mg/dL (5.6 mmol/L) at screening
- •3. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years.
- •4. On a stable lipid-modifying diet with or without medications (eg, statins, niacin, omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to screening
- •5. BMI index of 18-40 kg/m2
- •6. Provide signed informed consent
- •7. Willing and able to comply with clinic visits and study-related procedures
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of screening
- •2. Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to undergo apheresis or plasma exchange during the time frame of the study
- •3. History of class 3/4 heart failure at any time in the past, or hospitalization for heart failure, diagnosis of a myocardial infarction, stroke, TIA, unstable angina, CABG, PCI, carotid surgery/stenting within 3 months before the screening visit
- •4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia, or contraindications to receiving heparin (eg, allergic reaction to heparin)
- •5. New clinically significant findings on 12-lead electrocardiogram (ECG) that would place the patient at risk or interfere with participation in the study
- •6. Women of childbearing potential (WOCBP)* who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug.
- •*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Postmenopausal status will be confirmed by measurement of follicle-stimulating hormone (FSH). Pregnancy testing and contraception are not required for women with documented hysterectomy and/or oophorectomy.
- •7. Men who are sexually active with WOCBP and are unwilling to consistently use condoms during the study drug treatment period and for 24 weeks after the last administration of study drug, regardless of vasectomy status. Sperm donation is prohibited during the study and for up to 24 weeks after the last administration of study drug.
研究者
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