Status:
RECRUITING
Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
Lead Sponsor:
The Cleveland Clinic
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
21-65 years
Brief Summary
Inflammatory responses in response to alcohol have been identified as contributing to the development of alcoholic hepatitis. The inflammatory response including that to LippoPolySaccharide is known t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04088370
Start Date
October 8 2019
End Date
December 1 2026
Last Update
November 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195