Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorUniversity of Milano Bicocca
About this trial
Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. No AIH-specific registry does exist in Italy, so that the actual epidemiology of the disease in the country is unknown.
This is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects \> 1 years old in Italy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All AIH patients living in Italy and aged at least 1 year can be included in the database.
Willing and able to give informed consent prior to any study specific procedure being
Diagnosis of AIH according to the most recent published guidelines (EASL)
Disqualifiers
Subject unwilling to participate at the study
Trial population
Italian AIH patients (diagnosis of AIH according to the most recent published guidelines EASL) aged at least 1 year
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical Information
Other interventionWe will recruit AIH patients and collect important clinical information and laboratory investigation, together with biological samples.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: AIH patients1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 months
Number of participants with Normalization of AST and ALT \<1 x upper limit of normal (ULN)) and normal IgG levels within 6 monthswithin 6 months
Time frame
Overall duration of the study (11 years)2
Number of participants with lack of biochemical response
Number of participants with lack of biochemical response
Time frame
Overall duration of the study (11 years)3
Number of participants with <50% decrease of AST and ALT within 4 weeks after initiation of treatment
Number of participants with \<50% decrease of AST and ALT within 4 weeks after initiation of treatment
Time frame
Overall duration of the study (11 years)4
Number of participants with Hepatitis Activity Index <4/18
Number of participants with Hepatitis Activity Index \<4/18
Time frame
Overall duration of the study (11 years)Secondary outcomes
1
Liver stiffness
Liver stiffness by fibroscan
Time frame
Overall duration of the study (11 years)2
Number of participants achieving HAI score < 4 at follow-up biopsies
Number of participants achieving HAI score \< 4 at follow-up biopsies
Time frame
Overall duration of the study (11 years)3
The time from the diagnosis of AIH to an event
Date of diagnosis of AIH: Defined as the date of the diagnostic liver biopsy, or the date of the first abnormal AST or ALT, or the date of starting therapy in those cases that did not perform a liver biopsy at baseline but fulfilled diagnostic criteria for the disease. Events: Defined as follows: (1) death from a liver-related cause, meaning liver failure, variceal hemorrhage, or HCC; (2) Liver Transplantation for AIH
Time frame
Overall duration of the study (11 years)Sponsors and contacts
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Source ClinicalTrials.gov