Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

• Ursodeoxycholic acid combination of immunosuppressive agents (Drug): Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
• Ursodeoxycholic Acid (Drug): Ursodeoxycholic Acid

Primary outcomes

• Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH) [Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents]

Secondary outcomes

• Alanine transaminase (ALT) [Week 2 and Month 1, 3, 6]
• Aspartate transaminase(AST) [Week 2 and Month 1, 3, 6]
• Immunoglobulin G(IgG) [Week 2 and Month 1, 3, 6]
• Globin(GLB) [Week 2 and Month 1, 3, 6]
• Total bilirubin(TB) [Week 2 and Month 1, 3, 6]
• Direct bilirubin(DB) [Week 2 and Month 1, 3, 6]
• Alkaline phosphatase(ALP) [Week 2 and Month 1, 3, 6]
• Glutamyltransferase(GGT) [Week 2 and Month 1, 3, 6]
• Side effects [Evaluation of side effects during the study period(6 months)]

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* 1.Patients aged 18-70 years;
* 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
* 3.White blood cell count ≥2.5x10\^9/L or platelet count ≥50x10\^9/L at inclusion;
* 4.Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

* 1\. The presence of hepatitis A, B, C, D, or E virus infection;
* 2\. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.
* 3\. Patients with complications of cirrhosis;
* 4\. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
* 5\. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
* 6\. Pregnant and breeding women;
* 7\. Severe disorders of other vital organs, such as severe heart failure, cancer;
* 8\. Parenteral administration of blood or blood products within 6 months before screening;
* 9\. Recent treatment with drugs having known liver toxicity;
* 10.Taken part in other clinic trials within 6 months before screening.

• Li Yang, MD, Study chair, West China Hospital,Chengdu, Sichuan, China