Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis

Study Overview
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Brief Summary
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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.

Official Title
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Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis

Conditions
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Hepatitis, Autoimmune

Intervention / Treatment
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* Drug: Paeoniflorin + phosphatidylcholine or silymarin
* Drug: Phosphatidylcholine or silymarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Paeoniflorin + phosphatidylcholine or silymarin<br>Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin | Drug: Paeoniflorin + phosphatidylcholine or silymarin<br> <br> * Other names: total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin;|
| Active Comparator: Phosphatidylcholine or silymarin<br>Phosphatidylcholine or silymarin | Drug: Phosphatidylcholine or silymarin<br> <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 AIH | Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits | Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only | 

Secondary Outcome Measures

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