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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Closed for enrollment

La Crosse, Wis.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Closed for enrollment

Albert Lea, Minn.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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