Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis
Not Applicable
- Conditions
- Hepatitis, Autoimmune
- Interventions
- Other: Plasma exchange combination of immunosuppressive regimens
- Registration Number
- NCT02874586
- Lead Sponsor
- Xiaoli Fan
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Plasma exchange combination of immunosuppressive regimens Plasma exchange combination of immunosuppressive regimens Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis
- Primary Outcome Measures
Name Time Method Percent of patients that achieve biochemical remission of AIH Month 6 after the treatment initiated
- Secondary Outcome Measures
Name Time Method Alanine transaminase (ALT) Day 1, and Week 1, 2, 4, 12, 24 Globin(GLB) Day 1, and Week 1, 2, 4, 12, 24 Total bilirubin(TB) Day 1, and Week 1, 2, 4, 12, 24 Immunoglobulin G(IgG) Day 1, and Week 1, 2, 4, 12, 24 Direct bilirubin(DB) Day 1, and Week 1, 2, 4, 12, 24 Aspartate transaminase(AST) Day 1, and Week 1, 2, 4, 12, 24
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China