A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Biochemical remission
研究概览
简要总结
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.
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 18-70 years;
- •Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- •Agreed to participate in the trial, and assigned informed consent;
- •The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
排除标准
- •The presence of hepatitis A, B, C, D, or E virus infection;
- •Patients with presence of serious decompensated cirrhosis;
- •Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
- •Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease.
- •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 enrollment.
研究组 & 干预措施
Methylprednisolone and Mycophenolate mofetil
干预措施: Methylprednisolone and Mycophenolate mofetil (Drug)
Methylprednisolone and Azathioprine
干预措施: Methylprednisolone and azathioprine (Drug)
结局指标
主要结局
Biochemical remission
时间窗: 6 months
The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group
次要结局
- Adverse drug reactions(up to 6 months)
- The level of IgG value in both groups(at 6-month)
研究者
Xiaoli Fan
Doctor
West China Hospital