NCT06685692已完成2 期
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Treatment-Emergent Adverse Event Query
研究概览
简要总结
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 21 years old on the day of signing the informed consent form;
- •Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening
- •Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment
- •Ability and willingness to swallow tablets
- •Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements
排除标准
- •Pregnant, intending to become pregnant (or father a child), or breastfeeding
- •Current or recent enrollment in another interventional trial in the 30 days prior to screening
研究组 & 干预措施
ADX-629 (250 mg twice daily)
Experimental
干预措施: ADX-629 (Drug)
ADX-629 (125 mg twice daily)
Experimental
干预措施: ADX-629 (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Event Query
时间窗: Day 1 to Day 28
Incidence and severity of treatment-emergent adverse events
次要结局
未报告次要终点
研究者
研究点 (6)
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