Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Percent of patients that achieve biochemical remission of AIH
研究概览
简要总结
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-70 years;
- •Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
- •High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
- •High levels of IgG(1-1.5 X ULN);
- •Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
- •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 liver cirrhosis or portal hypertension;
- •Patients with presence of fulminant liver failure;
- •Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
- •Pregnant and breeding women;
- •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 screening.
研究组 & 干预措施
Paeoniflorin + phosphatidylcholine or silymarin
Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin
干预措施: Paeoniflorin + phosphatidylcholine or silymarin (Drug)
Phosphatidylcholine or silymarin
Phosphatidylcholine or silymarin
干预措施: Phosphatidylcholine or silymarin (Drug)
结局指标
主要结局
Percent of patients that achieve biochemical remission of AIH
时间窗: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits
次要结局
- Alanine transaminase (ALT)(Month 1, 3, 6)
- Aspartate transaminase(AST)(Month 1, 3, 6)
- Immunoglobulin G(IgG)(Month 1, 3, 6)
- Globin(GLB)(Month 1, 3, 6)
- Total bilirubin(TB)(Month 1, 3, 6)
- Direct bilirubin(DB)(Month 1, 3, 6)
研究者
Xiaoli Fan
Principal Investigator
West China Hospital