Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

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

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).

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.