Skip to content

Progression of fibrosis in treated autoimmune hepatitis

Progression of fibrosis in treated autoimmune hepatitis - Fibrosis in AIH

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52943
Enrollment
300
Registered
2019-07-22
Start date
2019-09-06
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune hepatitis

Interventions

None listed

Sponsors

Maag Darm en Leverziekten
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Main endpoint is a multivariate regression of treatment response, fibrosis and immunological markers for predicting increase in fibrosis as measured by liver elastography

Secondary

MeasureTime frame
Amount of fibrosis at inclusion Difference in fibrosis at inclusion and 5 years Correlation between fibrosismarkers, immunological markers and liver stiffness Quality of life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)