Creating a database for Autoimmune Hepatitis patients in Italy
Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
This study is creating a database to collect important health information about Autoimmune Hepatitis patients in Italy to better understand how the disease affects them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT06078098 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a comprehensive database for Autoimmune Hepatitis (AIH) patients in Italy, linking clinical information with biological sample storage. It will evaluate the incidence, prevalence, and disease course of AIH in individuals over one year old, addressing the lack of specific registries in the country. By employing both retrospective and prospective methodologies, the study seeks to provide a clearer understanding of the disease's epidemiology and its impact on patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged one year and older diagnosed with Autoimmune Hepatitis living in Italy.
Not a fit: Patients who are unwilling to participate in the study will not benefit from this initiative.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of Autoimmune Hepatitis, ultimately enhancing patient care and outcomes.
How similar studies have performed: While there have been few population-based studies on Autoimmune Hepatitis, this approach is relatively novel in Italy and aims to fill a significant gap in the existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Subject unwilling to participate at the study
Where this trial is running
Monza, MB
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Recruiting)
Study contacts
- Study coordinator: Pietro Invernizzi, MD
- Email: pietro.invernizzi@unimib.it
- Phone: 039 233 2187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.