EUCTR2018-003476-12-NL进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the effects of evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial Dysbetalipoproteinemia - EVOLVE-FD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. Patients diagnosed with Familial Dysbetalipoproteinemia;
- •*e2e2 genotype or dominant APOE mutation genotype (confirmed by genotyping or isoelectric focusing) with any lipid-lowering treatment at a stable dose for at least three months and non-HDL-C >1.6 mmol/L or;
- •*Patients with e2e2 genotype or dominant APOE mutation (confirmed by genotyping or isoelectric focusing) without lipid-lowering treatment and with an ApoB/TC ratio < 0.15.
- •2. >18 years old (on the day of signing informed consent).
- •3. Women are postmenopausal and not receiving hormone therapy (including cyclic and non-cyclical hormone replacement therapy or any estrogen antagonist/agonist). Postmenopausal status is defined as:
- •*no menses for =3 years or;
- •*no menses for =1 year but <3 years and confirmed by FSH levels elevated into the postmenopausal range (15-150 IU/L).
- •4. Willingness to maintain a stable diet for the duration of the study.
- •5. Understanding of the study procedures, alternative treatments available, and risks
- •involved with the study and voluntarily agreement to participate by giving written
- •informed consent.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Intolerance, known allergy or hypersensitivity to evolocumab (or other PCSK-9 monoclonal antibodies) or any of the components of the medication.
- •2. Current or prior exposure to evolocumab or another PCSK9-inhibitor mAb in the past 12 weeks.
- •3. Unable or unwilling to drink an oral fat load.
- •4. Uncontrolled diabetes as defined by a HbA1c >69 mmol/L at visit 1 (screening visit).
- •5. BMI >40 kg/m2 at visit 1 (screening visit).
- •6. Uncontrolled blood pressure with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg at visit 1 (screening visit).
- •7. Increased hepatic enzymes, defined as alanine transaminase (ALAT) or aspartate transaminase (ASAT) >3 times the ULN, or active liver disease defined as cirrhosis or Child Pugh B and C, or history of chronic active hepatitis B or C; participants with documented resolution after treatment are permitted.
- •8. Impaired renal function, defined by an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, and/or need of renal placement therapy or other clinically significant renal disease.
- •9. (Sub)clinical hypothyroidism: defined as TSH >5.0 mcl/U/mL at visit 1 (screening visit).
- •10. Increased levels of creatinine kinase defined as >3 times the ULN at visit 1 (screening visit).
- •11. Increased fasting levels of triglycerides defined as >10 mmol/L at visit 1 (screening visit).
- •12. History of organ transplantation and/or use of immunosuppressive medication.
- •13. Use of fish oil or red yeast rice <6 weeks prior to the study.
- •14. Active malignancy (<2 year prior to informed consent), except non-melanoma skin cancer or carcinoma in situ of the cervix.
- •15. Known infection with Human Immunodeficiency Virus (HIV) or AIDS.
- •16. Known celiac disease or other disorder associated with significant intestinal malabsorption.
- •17. Known galactose-intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
- •18. Alcohol use, defined as >14 alcoholic consumptions per week for women and >21 alcohol consumptions per week for men. One alcohol consumption unit is defined as follows: 350 mL beer, 150 mL wine or 45 mL alcohol for mixed drinks.
- •19. Current participation or participation in a study with an investigational compound or device within 30 days of signing informed consent.
- •20. Any medical, social or physiological circumstance which interferes the study, based on judgement by the principal investigator.
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