Autoimmune hepatitis
Conditions
Interventions
In the TAC group baseline treatment will be replaced by tacrolimus. In the MMF
group baseline treatment will be replaced by MMF. The current dose of
prednisolone, or at least 5 mg daily, will be con
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patient is older than 18 years old • Probable or definite auto immune hepatitis according to the original or simplified IAIHG criteria (>10 points pre-treatment on the original criteria or >6 points on the simplified criteria)(2, 3) • Incomplete responder on at least a half year of first-line treatment, with at least last 6 months azathioprine / 6-MP) / 6-TG and prednisolone or budesonide, and ALT 1.5 - 10x ULN for at least 2 months • Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: • Presence of decompensated liver disease, defined as ascites, coagulopathy (INR >1.5), encephalopathy, variceal bleed, hepatopulmonal syndrome, hepatorenal syndrome or HCC in the past 6 months • Signs of other liver diseases as NAFLD, Wilson disease, hemochromatosis, alcoholic liver disease or hepatitis B/C/D • Clinical diagnosis of overlap / variant syndrome with PBC or PSC • Liver transplantation in the medical history or currently on the waiting list for liver transplantation • Incompliance with therapy during the last 12 months • Active infections during inclusion including latent tuberculosis and HIV co-infection • Allergic or hypersensitive to tacrolimus or MMF • An estimated glomerular filtration rate (eGFR) of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in proportion of patients with CR at 12 months (normalization of ALT, AST and IgG) between the TAC and MMF treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters: - Safety and tolerability of TAC and MMF treatments - Difference in proportion of patients with CR at 6 months (normalization of ALT, AST and IgG) between the TAC and MMF treatment group. - Difference in ALT, AST and IgG at 6 and 12 months versus baseline - Difference in fibrogenesis and fibrosis parameters between groups and before and after treatment - Difference in quality of life between groups and before and after treatment | — |
Countries
Netherlands
Outcome results
None listed