NCT07644936Not yet recruiting
Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach
Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS "S. de Bellis". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07644936
What you commit to
- Study type: Observational
- Planned participants: 24
- From 1 Jul 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);
- Active oncological diseases;
- Viral hepatitis (HBV, HCV, HIV infection);
- Severe medical conditions that may compromise study participation
Age
- Adult age (≥18 years);
Other
- Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"
- Esclusion Criteria:
- Liver cirrhosis;
Who the study is looking for
- ARM A:
- Confirmed diagnosis of autoimmune hepatitis (AIH);
- Adult age (≥18 years);
- Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"
- ARM B:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS "S. de Bellis" - Nutritional Biochemistry Lab Coordinator of this site? Confirm its status | Castellana Grotte | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.