Hepatitis, Autoimmune
Conditions
Brief summary
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
Interventions
DRUGPaeoniflorin + phosphatidylcholine or silymarin
DRUGPhosphatidylcholine or silymarin
Sponsors
Xiaoli Fan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 20-70 years; * Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy; * High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN); * High levels of IgG(1-1.5 X ULN); * Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis); * 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; * Patients with presence of fulminant liver failure; * Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy; * Pregnant and breeding women; * 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 | Description |
|---|---|---|
| Percent of patients that achieve biochemical remission of AIH | Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only | Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits |
Secondary
| Measure | Time frame |
|---|---|
| Aspartate transaminase(AST) | Month 1, 3, 6 |
| Immunoglobulin G(IgG) | Month 1, 3, 6 |
| Alanine transaminase (ALT) | Month 1, 3, 6 |
| Total bilirubin(TB) | Month 1, 3, 6 |
| Direct bilirubin(DB) | Month 1, 3, 6 |
| Globin(GLB) | Month 1, 3, 6 |
Countries
China
Outcome results
None listed