NCT04617561Unknown4 期
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 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 low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
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
- •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 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, 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.
- •patients with contraindications of glucocorticoid
研究组 & 干预措施
Ursodeoxycholic Acid group
Active Comparator
Ursodeoxycholic Acid 13-15mg/kg/d
干预措施: Ursodeoxycholic acid (Drug)
Ursodeoxycholic Acid+Low Dose Glucocorticoid group
Experimental
Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period
干预措施: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) (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 treatment, per treatment group.
次要结局
- Minimal response(up to 12 months)
- Partial remission(up to 12 months)
- Side-effects(up to 12 months)
- Treatment failure(up to 12 months)
- ALT,AST,IgG(baseline and month 3,6,12)
- percentage of immune cells(baseline and month 12)
研究者
研究点 (1)
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