NCT04618575Unknown4 期
A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Biochemical remission
研究概览
简要总结
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years;
- •The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 1.0xULN < ALT ≤ 3.0xULN or 1.0xULN < AST ≤ 3.0xULN or 1.0xULN < IgG ≤ 1.3xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
- •Agreed to participate in the trial, and assigned informed consent.
排除标准
- •The presence of hepatitis A, B, C, D, or E virus infection;
- •Patients with presence of cirrhosis;
- •Patients with presence of fulminant liver failure;
- •Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease;
- •Pregnant and breeding women and women of childbearing age in need of reproduction;
- •Severe disorders of other vital organs, such as severe heart failure, cancer;
- •Parenteral administration of blood or blood products within 6 months before screening;
- •Recent treatment with drugs having known liver toxicity;
- •Taken part in other clinic trials within 6 months before enrollment.
研究组 & 干预措施
Ursodeoxycholic acid combined with total glucosides of paeony
Experimental
干预措施: Ursodeoxycholic acid combined with total glucosides of paeony (Drug)
Ursodeoxycholic acid only
Other
干预措施: Ursodeoxycholic acid only (Drug)
结局指标
主要结局
Biochemical remission
时间窗: up to 12 months
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
次要结局
- Partial remission(up to 12 months)
- Treatment failure(up to 12 months)
- Minimal response(up to 12 months)
- Side-effects(up to 12 months)
- Clinical symptoms(up to 12 months)
- Changes in the proportion of blood immune cells(up to 12 months)
研究者
研究点 (1)
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