NL-OMON53567尚未招募2 期
A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia - AROAPOC3-2003
Arrowhead Pharmaceuticals, Inc0 个研究点目标入组 7 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7
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. Adults >=18 years of age who are nonpregnant, nonlactating, and do not plan
- •to become pregnant during the study
- •2. Able and willing to provide written informed consent prior to the
- •performance of any study specific procedures
- •3. Completed the 48-week study treatment period in the parent study
排除标准
- •1. Subject was permanently discontinued from ARO-APOC3 in the parent study due
- •to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
- •2. Any new condition or worsening of existing condition (eg, renal,
- •hematologic, gastrointestinal, endocrine, cardiovascular, pulmonary,
- •immunologic, psychiatric) or any other situation that, in the Investigator*s
- •judgment, would make the subject unsuitable for enrollment, could interfere
- •with the subject participating in or completing the study, would make it
- •difficult to comply with protocol requirements, or put the subject at
- •additional safety risk
- •3. Unwilling to limit alcohol consumption to within moderate limits for the
- •duration of the study, as follows: not more than 14 units per week (1 unit
- •approximately corresponds to 80 mL of wine, 200 mL of beer, or 25 mL of 40%
研究者
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