ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02172898
Recruitment Status : Recruiting
First Posted : June 24, 2014
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Naga P. Chalasani, Indiana University

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.

Condition or disease
Alcoholic Hepatitis

Study Type : Observational
Estimated Enrollment : 1260 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
Study Start Date : June 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


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

Biospecimen Retention:   Samples With DNA
serum/plasma, peripheral mononuclear cells, genomic DNA, stool samples, urine, and liver tissue (where available)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172898


Contacts
Contact: Jennifer Lehman, RN (317) 278-1872 jgeck@iu.edu
Contact: Megan Comerford, BS, MPH 317-278-9226 mcomerfo@iu.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah Wilder, RN, BSN    507-284-2698    wilder.sarah@mayo.edu   
Principal Investigator: Vijay Shah, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Susan Walker, RN, MSN    804-628-4395    walkersa@vcu.edu   
Principal Investigator: Arun J Sanyal, MD         
Sponsors and Collaborators
Indiana University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Naga Chalasani, MD Indiana University

Additional Information:
Responsible Party: Naga P. Chalasani, Naga Chalasani, MD, FACG, Indiana University
ClinicalTrials.gov Identifier: NCT02172898     History of Changes
Other Study ID Numbers: TREAT Observational
U01AA021840-01 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders