NCT05476900已完成2 期
A Randomized, Open-label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune 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
- 69
- 试验地点
- 1
- 主要终点
- Percentage of biochemical response after 12 weeks of treatment.
研究概览
简要总结
This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old≤Female or male patients≤70 years old；
- •Clinical-confirmed autoimmune hepatitis；
- •Biopsy-confirmed autoimmune hepatitis；
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
- •Willing and able to give informed consent and follow the protocols during the trial.
排除标准
- •Patients with other chronic liver diseases；
- •Patients with liver cirrhosis；
- •Patients with hepatic encephalopathy；
- •Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
- •Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
- •Patients with severe cardiovascular diseases；
- •Patients with malignancy within the past 5 years；
- •Patients received organ transplantation；
- •Patients treated with any systemic corticosteroids within 3 months before screening；
- •Patients treated with any systemic immunosuppressive drugs within the 6 months before screening.
研究组 & 干预措施
12 mg HR19042 Capsules QD
Experimental
干预措施: HR19042 Capsules (Drug)
4 mg HR19042 Capsules TID
Experimental
干预措施: HR19042 Capsules (Drug)
8 mg HR19042 Capsules QD
Experimental
干预措施: HR19042 Capsules (Drug)
结局指标
主要结局
Percentage of biochemical response after 12 weeks of treatment.
时间窗: 12 weeks
次要结局
- Change from baseline in serum AST levels.(2, 4, 8, 12, 18, 24 weeks)
- Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.(24 weeks)
- Percentage of biochemical response after 24 weeks of treatment.(24 weeks)
- Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.(12 weeks)
- Percentage of partial response after 12 weeks of treatment(12 weeks)
- Percentage of partial response after 24 weeks of treatment.(24 weeks)
- Change from baseline in serum ALT levels.(2, 4, 8, 12, 18, 24 weeks)
研究者
研究点 (1)
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