Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Study Overview
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Brief Summary
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An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).

Official Title
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Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis

Conditions
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Hepatitis, Autoimmune

Intervention / Treatment
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* Other: Plasma exchange combination of immunosuppressive regimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy; High levels of total bilirubin (TB) (≥10 X ULN); High levels of immunoglobulin G(IgG) (≥1.5 X ULN); 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; Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy; Pregnant and breeding women; Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 2500/mm3), or thrombocytopenia (platelet count < 50,000/mm3); 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: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma exchange combination of immunosuppressive regimens<br>Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis | Other: Plasma exchange combination of immunosuppressive regimens<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 |  | Month 6 after the treatment initiated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alanine transaminase (ALT) |  | Day 1, and Week 1, 2, 4, 12, 24 | 
| Aspartate transaminase(AST) |  | Day 1, and Week 1, 2, 4, 12, 24 | 
| Globin(GLB) |  | Day 1, and Week 1, 2, 4, 12, 24 | 
| Immunoglobulin G(IgG) |  | Day 1, and Week 1, 2, 4, 12, 24 | 
| Total bilirubin(TB) |  | Day 1, and Week 1, 2, 4, 12, 24 | 
| Direct bilirubin(DB) |  | Day 1, and Week 1, 2, 4, 12, 24 |