Hepatitis, Autoimmune
Conditions
Brief summary
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).
Interventions
OTHERPlasma exchange combination of immunosuppressive regimens
Sponsors
Xiaoli Fan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients that achieve biochemical remission of AIH | Month 6 after the treatment initiated |
Secondary
| Measure | Time frame |
|---|---|
| Direct bilirubin(DB) | Day 1, and Week 1, 2, 4, 12, 24 |
| Alanine transaminase (ALT) | Day 1, and Week 1, 2, 4, 12, 24 |
| Total bilirubin(TB) | 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 |
| Aspartate transaminase(AST) | Day 1, and Week 1, 2, 4, 12, 24 |
Countries
China
Contacts
Primary ContactXiaoli Fan, MM
Outcome results
None listed