Alcoholic Hepatitis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Indiana University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Developing a repository of biological samples from AH patients and heavy drinking controls. | Up to 1 year | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies. | Up to 1 year |
Countries
United States
Outcome results
None listed