Clinical trial NCT02172898: Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
Official title: Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Hepatitis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-06-24
Enrollment: 454
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with AH and suitable controls will be enrolled at Indiana University and affiliated hospitals. In addition, the enrollment will be conducted simultaneously at Mayo Clinic and Virginia Commonwealth University with the same target enrollment.

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.


Eligibility 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

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

Primary outcomes:
measure: Developing a repository of biological samples from AH patients and heavy drinking controls.
timeFrame: Up to 1 year
Secondary outcomes:
measure: Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies.
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Indiana University
name: Naga Chalasani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madathanapalli A, Tang Q, Lammert C, Samala N, Shah VH, Sanyal A, Chalasani N, Desai AP. Health-related quality of life is dynamic in alcoholic hepatitis and responds to improvement in liver disease and reduced alcohol consumption. Alcohol Clin Exp Res. 2022 Feb;46(2):252-261. doi: 10.1111/acer.14756. Epub 2021 Dec 16.
citation: Mathur K, Vilar-Gomez E, Connelly MA, He H, Sanyal AJ, Chalasani N, Jiang ZG. Circulating high density lipoprotein distinguishes alcoholic hepatitis from heavy drinkers and predicts 90-day outcome: lipoproteins in alcoholic hepatitis. J Clin Lipidol. 2021 Nov-Dec;15(6):805-813. doi: 10.1016/j.jacl.2021.10.002. Epub 2021 Oct 20.
citation: Shamseddeen H, Madathanapalli A, Are VS, Shah VH, Sanyal AJ, Tang Q, Liang T, Gelow K, Zimmers TA, Chalasani N, Desai AP. Changes in Serum Myostatin Levels in Alcoholic Hepatitis Correlate with Improvement in MELD. Dig Dis Sci. 2021 Sep;66(9):3062-3073. doi: 10.1007/s10620-020-06632-5. Epub 2020 Oct 19.