RecruitingNCT06078098

Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage

Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage


Sponsor

University of Milano Bicocca

Enrollment

10,000 participants

Start Date

Mar 29, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 1 Year

Inclusion Criteria3

  • 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)

Exclusion Criteria1

  • Subject unwilling to participate at the study

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Interventions

OTHERClinical Information

We will recruit AIH patients and collect important clinical information and laboratory investigation, together with biological samples.


Locations(1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy

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NCT06078098


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