JPRN-jRCT2080224823已完成3 期
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male and female patients >=18 years of age with a diagnosis of functional HoFH.
- •2. Completion of the 1629 parent study in which they participated (if applicable)
- •3. Willing and able to comply with clinic visits and study-related procedures.
排除标准
- •1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient
- •2. Concomitant medications that have not been stable prior to the baseline visit
- •3. Adverse event leading to permanent discontinuation from parent study
- •4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
- •5. Member of the clinical site study team and/or his/her immediate family
- •6. Pregnant or breastfeeding women
- •7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug
- •8. Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug
研究者
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