Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-002715
- La Crosse, Wisconsin: 13-002715
- Albert Lea, Minnesota: 13-002715
NCT ID: NCT02172898
Sponsor Protocol Number: TREAT-001
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
- 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
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