Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Study Overview
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Brief Summary
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Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Official Title
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Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents

Conditions
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Hepatitis, Autoimmune, Cholangitis, Liver Cirrhosis, Biliary, Cholestasis

Intervention / Treatment
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* Drug: Ursodeoxycholic acid combination of immunosuppressive agents
* Drug: Ursodeoxycholic Acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ursodeoxycholic acid + immunosuppressive agents group<br>Ursodeoxycholic acid + immunosuppressive agents | Drug: Ursodeoxycholic acid combination of immunosuppressive agents<br>* Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)<br>|
| Active Comparator: Ursodeoxycholic acid group<br>Ursodeoxycholic acid | Drug: Ursodeoxycholic Acid<br>* Ursodeoxycholic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |