NCT05190523已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
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
- 98
- 试验地点
- 1
- 主要终点
- Percentage changes of alkaline phosphatase (ALP) compared with baseline.
研究概览
简要总结
This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤75 years old at screening.
- •Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:
- •Biochemical evidence of cholestasis based on ALP elevation.
- •Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
- •Liver biopsy consistent with PBC.
- •Screening ALP ≥ 1.67× ULN
- •Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.
排除标准
- •ALT or AST > 5× ULN; ALP >10× ULN
- •History or presence of other concomitant liver diseases
- •Child-Pugh grade B or C
研究组 & 干预措施
ASC42 tablets of 5mg
Experimental
ASC42 tablets 5mg for 12 weeks
干预措施: ASC42 5 mg (Drug)
ASC42 tablets of 10mg
Experimental
ASC42 tablets 10mg for 12 weeks
干预措施: ASC42 10 mg (Drug)
ASC42 tablets of 15mg
Experimental
ASC42 tablets 15mg for 12 weeks
干预措施: ASC42 15 mg (Drug)
Placebo
Placebo Comparator
Placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage changes of alkaline phosphatase (ALP) compared with baseline.
时间窗: Day85
次要结局
- Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.(Day15\29\57\85)
- Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.(Day15\29\57\85)
- Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.(Day15\29\57\85)
研究者
研究点 (1)
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