Scientists probe immune cell damage in heavy drinkers

NCT ID NCT04088370

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Recruiting now This study
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares immune cell function in 30 healthy volunteers, heavy drinkers, and people with alcoholic hepatitis. Researchers will analyze blood samples to measure how mitochondria (the cell's powerhouses) work and how cells respond to inflammation. The goal is to better understand why some heavy drinkers develop severe liver disease.

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 study could reveal how alcohol damages immune cells, pointing toward new targets for treating alcoholic hepatitis.
What could go wrong
This is a small, early observational study (30 participants) that only measures biological markers, not treatments. Results may not lead to direct therapies.

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 30 people

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

Started

Oct 2019

Expected to finish

Dec 2026

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

Patients with alcoholic hepatitis as diagnosed by liver biopsy, imaging, or biochemical values with noted encounter in Cleveland Clinic Electronic Medical Record, Heavy Drinking Controls - patients who lack any evidence (biochemical, imaging, and/or biopsy) of alcoholic liver disease who consume \>40 g/day or \>280g/week on average for women and \>60 g/day or \>420 g/week on average for men for a minimum of 6 months Healthy Controls - patients without any form of liver disease nd do not meet the criteria for "Heavy Drinking Controls"

Ages

21 to 65 years

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 of Subjects with Alcoholic Hepatitis (AH): \*diagnosis of AH either by imaging, biochemical values or liver biopsy as well as drinking history Inclusion Heavy Drinking Controls: \*heavy alcohol drinking will be defined as \>40 g/day or \>280g/week on average for women and \>60 g/day or \>420 g/week on average for men for a minimum of 6 months \[6\] and within the 4 weeks prior to study enrollment. Exclusion Criteria for all groups * inability or unwillingness to sign informed consent * cancer * autoimmune disease that in the opinion of the PI will confound study data Control subjects (drinking and non drinking) must meet the following criteria: * INR \< 1.4 * total bilirubin levels must \<3 * no prior history of known alcoholic liver disease * absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

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