Identify markers predicting progression of fibrosis in treated autoimmune hepatitis patients
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint is a multivariate regression of treatment response, fibrosis and
immunological markers for predicting increase in fibrosis as measured by liver
elastography
Secondary outcome
Amount of fibrosis at inclusion
Difference in fibrosis at inclusion and 5 years
Correlation between fibrosismarkers, immunological markers and liver stiffness
Quality of life
Background summary
Autoimmune hepatitis, a chronic autoimmune disease of the liver is treated with
immunosuppressants. One of the treatment goals in autoimmune hepatitis is the
prevention of progression of fibrosis and development of cirrhosis. Although
progression of fibrosis during therapy can occur knowledge of this phenomenon
is limited.
Study objective
Identify markers predicting progression of fibrosis in treated autoimmune
hepatitis patients
Study design
Multicenter, prospective observational cohort study
In all patients liver elastography and blood fibrosis markers and immunological
markers will be determined yearly for a 5 year period. Patients will be asked
to fill out a questionnaire regarding quality of life.
Study burden and risks
This is an observatory study and patients will not directly benefit. However,
the study will increase the knowledge of fibrosis progression in autoimmune
hepatitis from which patients may benefit in the long-term.
The burden the study adds is minor: Additional blood samples will be taken,
liver elastography will be performed and patients will be asked to fill in a
questionnaire.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68801.058.19 |