Autoimmune hepatitis
Conditions
Interventions
Trade Name: Prednisolon
Product Name: Prednisolon
Pharmaceutical Form: Tablet
Trade Name: Budesonid
Product Name: Various
Pharmaceutical Form: Capsule, hard
Sponsors
Umeå University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A written informed consent is signed before any study-related procedures are performed. 2. Male and female subjects aged =18 years of age. 3. A definitive diagnosis of autoimmune hepatitis with a score of =6 according to the "simplified AIH criteria". 4. A liver biopsy should, a) have been performed within the last 6 months, and, b) show interface inflammation grade of =1 according to the Ludwig-Batts grading scale. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Chronic liver disease other than AIH (PBC, PSC, viral hepatitis, hemochromatosis, homozygous alpha-1-antitrypsin deficiency and Wilson disease) 2. Ongoing immune-modulating therapy 3. Liver cirrhosis/fibrosis grade 4 according to Ludwig-Batts grading scale and/or clinically compensated or decompensated liver cirrhosis (signs of portal hypertension and/or cirrhosis on radiology, ultrasound or MRI). 4. Current malignancy 5. Alcohol overconsumption (B-PEth >0.3 µmol/L) 6. Contraindication to corticosteroids 7. Contraindication to azathioprine 8. Suggested non-compliance with the protocol. 9. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess differences in treatment effects between budesonide and prednisolone in non-cirrhotic newly diagnosed AIH patients with respect to time to remission and percentage of patients reaching complete and incomplete remission, and number of flares.;Secondary Objective: To assess (i) the side effects of budesonide (BUD) vs prednisolone (PRED) regarding diabetes (ii) the side effects of BD vs PRED regarding osteoporosis (change at 1 year from baseline) (iii) the side effects of BUD vs PRED on body weight at week 26 and 52 (iv) the side effects of BUD vs PRED on the skin at week 26 and 52 (presence of striae, moon face, hirsutism at week 26 and 52) (v) the side effects of BUD vs PRED on QoL (SF36, SHS and WPAI-GH at baseline, week 4 and week 52) (vi) the effects of BUD vs PRED on liver biopsy (changes in scores from baseline to week 52) (vii) the effects of BUD vs PREDe on Fibroscan scores at week 13, 26 and 52. (viii) the effects of BUD vs PRED on inflammatory markers such as TNF, IL6 and genetic markers on inflammation at week 52 compared with baseline. (ix) the effects of BUD vs PRED on laboratory markers, such as ASAT, ALAT, GT, ALP, Bilirubin and IgG.;Primary end point(s): Complete laboratory remission of AIH (defined as normalized ALAT, ASAT and IgG) in each group.;Timepoint(s) of evaluation of this end point: One year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to complete remission - Frequency of partial remission (ALAT and/or ASAT reduced to 1-2x ULN) - Time to partial remission - Frequency of non-responders - Frequency of relapsing AIH/flares (increased ALAT from normal to >3 ULN) - Differences in QoL-scores from baseline to week 4 and 52 - Differences in Fibroscan scores from baseline to week 13, 26 and 52 - Differences in densitometry-scores from baseline to week 52 - Differences in Batts & Ludwig scores from baseline to week 52;Timepoint(s) of evaluation of this end point: One year | — |
Countries
Sweden
Contacts
Public ContactHanns-Ulrich Marschall
Sahlgrenska Academy
Outcome results
None listed