Progression of fibrosis in treated autoimmune hepatitis
Recruiting
- Conditions
- Autoimmune hepatitis1001965410003816
- Registration Number
- NL-OMON52943
- Lead Sponsor
- Maag Darm en Leverziekten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Patients are older than 18 years old
Patients with AIH (at least probable according to the simplified criteria) or
overlapsyndrome
Patients are treated for at least 6 months
Patients have given written informed consent to participate in the study
Exclusion Criteria
Current flair of autoimmune hepatitis (ALT more than 3 times the upper limit of
normal)
Patients with signs of other liver diseases as NASH, alcoholic liver disease,
viral hepatitis, hemochromatosis or Wilson's disease
Patients with current decompensated liver disease (recompensated patients can
be included)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main endpoint is a multivariate regression of treatment response, fibrosis and<br /><br>immunological markers for predicting increase in fibrosis as measured by liver<br /><br>elastography</p><br>
- Secondary Outcome Measures
Name Time Method <p>Amount of fibrosis at inclusion<br /><br>Difference in fibrosis at inclusion and 5 years<br /><br>Correlation between fibrosismarkers, immunological markers and liver stiffness<br /><br>Quality of life</p><br>