Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Xiaoli Fan

Status

Unknown

Conditions

Hepatitis, Autoimmune

Treatments

Other: Plasma exchange combination of immunosuppressive regimens

Study type

Interventional

Funder types

Other

Identifiers

NCT02874586

AIH-2

Details and patient eligibility

About

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).

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.