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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:

6/23/2014

NCT ID:

NCT02172898

IRB Number:

13-002715