Clinical Trial

Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach

Study acronym: AIH-LIPID
Not Yet Recruiting
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Summary
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-06-08; most recent amendment 2026-07-14.
Trial Details
NCT Number NCT07644936
Lead Sponsor Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions Autoimmune Hepatitis, Non-Alcoholic Fatty Liver Disease
Enrollment 24 participants
Start Date 2026-07-01
Primary Completion 2027-07-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-15