Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
NCT ID: NCT04088370
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2019-10-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Alcoholic Hepatitis
No intervention-blood draw only
Blood Draw
Blood Draw Only
Healthy Controls
No intervention- blood draw only
Blood Draw
Blood Draw Only
Healthy Heavy Drinkers
No intervention- blood draw only
Blood Draw
Blood Draw Only
Interventions
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Blood Draw
Blood Draw Only
Eligibility Criteria
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Inclusion Criteria
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
* 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.
21 Years
65 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Srinivasan Dasarathy
Staff Physician
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-1041
Identifier Type: -
Identifier Source: org_study_id
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