Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Study Overview
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Brief Summary
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To conduct a prospective, multicenter, observational study of patients with well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository will be developed from both cases and controls.

Official Title
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Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Conditions
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Alcoholic Hepatitis

Participation Criteria
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Eligibility Criteria
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CASES: Heavy drinkers with alcoholic hepatitis Inclusion criteria 1. The diagnosis of AH will be established on published criteria this is based on: Average daily ethanol consumption of > 40 grams/day for women and > 60 grams/day for men for a minimum of 6 months and within the 6 weeks prior to study enrolment. Judgment regarding daily and yearly alcohol use will be made by the site investigator Clinical evaluation and appropriate laboratory testing as defined by total bilirubin > 2 mg/dL and AST > 50 U/L. When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required. Subjects with HBV, HCV and/or HIV will be eligible for enrollment Exclusion criteria Evidence of other liver diseases such as autoimmune or drug-induced Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure Abstinence of alcohol use > 6 weeks immediately preceding enrollment Hemochromatosis Wilson Disease Active intravenous drug use CONTROLS: Heavy drinkers without alcoholic hepatitis Inclusion criteria Average daily ethanol consumption of > 40 grams /day for women and > 60 grams/day for males for a minimum of 6 months and within the 6 weeks prior to study enrollment. In addition, heavy drinkers who have just become abstinent within prior 2 weeks are eligible to be enrolled. Judgment regarding daily and yearly alcohol use will be made by the site investigator AST and ALT ≤ 50 and total bilirubin levels within normal range. If bilirubin is increased due to a suspected Gilbert's Syndrome, patient may be enrolled if the direct bilirubin is within normal limits Exclusion criteria Evidence of liver disease Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure Abstinence of alcohol use > 2 weeks immediately preceding enrollment Hemochromatosis Wilson Disease Active intravenous drug use Prior history of known alcoholic liver disease Presence of hepatosplenomegaly from the physical examination/radiographic imaging or stigmata of liver disease

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heavily Drinking Controls<br>Heavy alcohol drinking will be defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment. Heavy drinkers, who have just become abstinent within prior 2 weeks, including those we convince to seek treatment as part of the recruiting process, are eligible for enrollment. Control subjects must meet the following criteria: (1) AST, ALT, and total bilirubin levels must be within normal range; (2) no prior history of known alcoholic liver disease; and (3) absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease. | |
| Subjects with AH<br>Diagnosis of AH will be established on published criteria based on history of heavy alcohol consumption (defined as > 40 grams per day on average in women and > 60 grams per day on average for men for a minimum of 6 months and within the 6 weeks prior to study enrollment), clinical evaluation and appropriate laboratory testing (as defined as total bilirubin > 2 mg/dL and AST > 50 U/L). When diagnosis of AH remains in question, a liver biopsy (if clinically feasible and subject has no contraindications) will be required. We plan to enroll patients with AH in special population infected with hepatitis B (HBV), hepatitis C (HCV), or HIV. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developing a repository of biological samples from AH patients and heavy drinking controls. | To conduct a prospective, multicenter, observational study of patients with well-characterized AH and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository of serum/plasma, peripheral mononuclear cells, genomic DNA, stool samples, urine, and liver tissue (where available) will be developed from both cases and controls. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies. |  | Up to 1 year |