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

CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

1. The diagnosis of AH will be established on published criteria this is based on:

1. 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

2. 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.

3. Subjects with HBV, HCV and/or HIV will be eligible for enrollment

Exclusion criteria

1. Evidence of other liver diseases such as autoimmune or drug-induced

2. Significant concomitant medical illnesses such as uncontrolled congestive heart
failure or COPD, or multiorgan failure

3. Abstinence of alcohol use > 6 weeks immediately preceding enrollment

4. Hemochromatosis

5. Wilson Disease

6. Active intravenous drug use

CONTROLS: Heavy drinkers without alcoholic hepatitis

Inclusion criteria

1. 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

2. 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

1. Evidence of liver disease

2. Significant concomitant medical illnesses such as uncontrolled congestive heart
failure or COPD, or multiorgan failure

3. Abstinence of alcohol use > 2 weeks immediately preceding enrollment

4. Hemochromatosis

5. Wilson Disease

6. Active intravenous drug use

7. Prior history of known alcoholic liver disease

8. Presence of hepatosplenomegaly from the physical examination/radiographic imaging or
stigmata of liver disease