Multicenter, Nationwide, Observational, Retrospective and Prospective Study to Develop an Autoimmune Hepatitis Patient Database and Biological Sample Storage

What this Trial Is About

Autoimmune Hepatitis (AIH) is a chronic liver disease characterized by ongoing inflammation that can lead to liver failure and the need for transplantation. Both children and adults are affected, with some patients facing reduced life expectancy despite treatment. This study aims to develop a national registry in Italy to better understand the incidence, prevalence, disease progression, and impact of AIH, as well as to assess safety and long-term effects of new therapies. It is an observational, multicenter, retrospective and prospective study focusing on patients older than 1 year. The study will enroll approximately 10,000 AIH patients across Italy over a 120-month period, collecting clinical information, laboratory tests, and biological samples. There is no experimental treatment involved; instead, the study gathers data from patients diagnosed according to recent guidelines. Patients will be followed for a minimum of one year to monitor disease course and outcomes. Participants will provide clinical data and biological samples during the study, with ongoing assessments of liver function and disease activity using various blood tests and liver stiffness measurements. Researchers will track biochemical responses, disease relapse, liver complications requiring hospital admission, and other laboratory indicators over the 11-year study duration. This long-term monitoring will help characterize AIH progression and treatment safety in the Italian population.

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