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Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach

Study acronym: AIH-LIPID
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Secondary endpoints revised (3)v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07644936
Lead Sponsor Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions
(from sponsor)		 Autoimmune Hepatitis, Non-Alcoholic Fatty Liver Disease
Related terms Hepatitis, Autoimmune, Non-alcoholic Fatty Liver Disease
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov