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

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172898
• Other study ID #: TREAT Observational
• Secondary ID: U01AA021840-01
• Status: Completed
• Start date: June 2013
• Est. completion date: July 2019

Study information

• Verified date: February 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: July 2019
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Developing a repository of biological samples from AH patients and heavy drinking controls.	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.	Up to 1 year
Secondary	Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies.		Up to 1 year