Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
Completed
Conditions studied: Alcoholic Hepatitis
In brief
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.
Key facts
- Study ID
- NCT02172898
- Run by
- Indiana University
- People needed
- 454
- Starts
- 2013-06-01
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2020-02-11
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.