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New blood test may sharpen diagnosis of autoimmune liver disease

NCT ID NCT05810480

Diagnosis Sponsor: Hannover Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study evaluates whether a blood test measuring polyreactive immunoglobulin G (pIgG) can more accurately diagnose autoimmune hepatitis (AIH) and distinguish it from other liver conditions. Researchers will collect blood samples from 400 adults undergoing liver biopsy for suspected liver disease. The goal is to see if pIgG testing improves upon standard autoantibody tests, especially in cases where conventional tests are negative or misleading.

What this could mean

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

Active substance
polyreactive immunoglobulin G (pIgG) diagnostic test
What this could lead to
If successful, this test could provide a more accurate way to diagnose autoimmune hepatitis, reducing misdiagnosis and unnecessary treatments.
What could go wrong
This is a diagnostic study, not a treatment trial. The test may not prove superior to existing methods, and results may not apply to all patient groups.

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 400 people

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

Started

Jun 2023

Expected to finish

Jan 2029

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

Any patient that presents to the respective hospital for evaluation of a so far unknown-liver disease and consents is eligible if the treating physician orders a liver biopsy for the diagnostic evaluation of the liver disease. Patients are not eligible if a liver biopsy is performed for staging or grading of an already known liver disease or if the patient is treated with immunosuppressive drugs at the time of the liver biopsy.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Diagnostic liver biopsy for the work-up of any liver disease * Informed consent * Definition of any liver disease according to current societal guidelines Exclusion Criteria: * Ongoing immunosuppression at the liver biopsy or prior to the liver biopsy * Liver biopsies for the grading or staging of an already known liver disease (e.g. non-alcoholic fatty liver disease (NAFLD), Hepatitis B/D Virus Infections (HBV/HDV Infection), …) * known liver disease * missing informed consent * patients or caregivers who can not provide informed consent

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis hepatitis B virus infection hepatitis D virus infection 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 Autoimmune 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

    6 sites. 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

  • Hannover Medical School

    RECRUITING

    Hanover, 30625, Germany

  • RWTH Aachen

    NOT_YET_RECRUITING

    Aachen, Germany

  • Rostock University Medical Centre

    NOT_YET_RECRUITING

    Rostock, 18057, Germany

  • University Hospital Schleswig-Holstein, Location Lübeck

    NOT_YET_RECRUITING

    Lübeck, 23562, Germany

  • University Medical Center Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, 20251, Germany

  • University Medical Center Heidelberg

    NOT_YET_RECRUITING

    Heidelberg, 69120, Germany

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