NL-OMON42421已完成2 期
A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) (study CB8025-21427) - CB8025-21427 (CymaBay)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
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
- •1. Written informed consent.
- •2. Male or female with HoFH confirmed by genotype (two mutant alleles at the LDL-Receptor gene locus)
- •3. 18 years of age or older
- •4. Existing lipid lowering therapies (statins, cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid and their combinations, LDL-C apheresis) on a stable regimen for at least four weeks before Screening Visit.
- •5. Stable lipid lowering diet compatible with a Step I diet of the American Heart Association.
- •6. Fasting LDL-C > 4.8 mmol/L during screening.
- •7. For females or males of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose.
排除标准
- •1. Treatment with lomitapide or mipomersen within two months of screening.
- •2. Heart Failure NYHA class lll-IV or LVEF <30%.
- •3. Uncontrolled cardiac arrhythmia during the pastthree months of screening.
- •4. Myocardial infarction, unstable angina, PCI, CABG orstroke during the pastthree months prior to screening.
- •5. Planned cardiac surgery, or revascularization, in the next four months.
- •6. Uncontrolled hypertension.
- •7. AST or ALT >3 times the ULN.
- •8. Unexplained CK >5 times the ULN.
- •9. For females, pregnancy or breast-feeding.
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