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

February 10, 2020 updated by: Naga P. Chalasani, Indiana University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

454

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Heavily Drinking Controls
Heavy alcohol drinking will be defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment. Heavy drinkers, who have just become abstinent within prior 2 weeks, including those we convince to seek treatment as part of the recruiting process, are eligible for enrollment. Control subjects must meet the following criteria: (1) AST, ALT, and total bilirubin levels must be within normal range; (2) no prior history of known alcoholic liver disease; and (3) absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
Subjects with AH
Diagnosis of AH will be established on published criteria based on history of heavy alcohol consumption (defined as > 40 grams per day on average in women and > 60 grams per day on average for men for a minimum of 6 months and within the 6 weeks prior to study enrollment), clinical evaluation and appropriate laboratory testing (as defined as total bilirubin > 2 mg/dL and AST > 50 U/L). When diagnosis of AH remains in question, a liver biopsy (if clinically feasible and subject has no contraindications) will be required. We plan to enroll patients with AH in special population infected with hepatitis B (HBV), hepatitis C (HCV), or HIV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developing a repository of biological samples from AH patients and heavy drinking controls.
Time Frame: Up to 1 year
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 Outcome Measures

Outcome Measure
Time Frame
Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies.
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Naga Chalasani, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREAT Observational
  • U01AA021840-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcoholic Hepatitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe