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Blood fats and nanoparticles may reveal hidden clues in autoimmune liver disease

NCT ID NCT07644936

Knowledge-focused Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study looks at two types of liver disease — autoimmune hepatitis and non-alcoholic fatty liver disease — to see if fats in blood cells and tiny particles called extracellular vesicles differ between them. Researchers will collect blood samples from 24 adults and analyze these components. The goal is to find new ways to tell these diseases apart and possibly discover targets for future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could identify new biomarkers to better diagnose or monitor autoimmune hepatitis without invasive biopsies.
What could go wrong
This is a small pilot study with only 24 participants, so findings may not apply broadly. It is observational and does not test any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

dult outpatients with AIH or NAFLD diagnosis attending the UOSD Epatopatie at IRCCS "S. de Bellis", Castellana Grotte (BA), Italy

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: Exclusion Criteria: * Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD); * Adult age (≥18 years); * Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis" Esclusion Criteria: * Liver cirrhosis; * Active oncological diseases; * Viral hepatitis (HBV, HCV, HIV infection); * Severe medical conditions that may compromise study participation

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune hepatitis Non-alcoholic fatty liver disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS "S. de Bellis" - Nutritional Biochemistry Lab

    Castellana Grotte, Bari, 70013, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.