Alcoholic Hepatitis Network Observational Study

Completed

Conditions studied: Alcoholic Hepatitis

In brief

The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, saliva, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcoholic hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcoholic hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A "biological sample" is usually blood, but can be any body fluid. "Personal Health Information" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.

Key facts

Study ID

NCT03850899

Run by

Indiana University

People needed

1133

Starts

2019-04-17

Expected to finish

2024-06-21

Last updated by the study team

2025-02-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A clinical diagnosis of alcoholic hepatitis as defined by the NIAAA pan-consortia for AH:
• Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit
• Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice
• AST > 50 IU/l
• AST:ALT > 1.5 and both values < 400 IU/l
• and/or histological evidence of AH*
• Serum total bilirubin >3 mg/dL
• Subject or guardian ability to understand and willingness to provide written consent
• Age greater or equal to 21 years
• Re-enrolment of an alcoholic hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcoholic hepatitis 24 weeks or longer after the most recent enrolment in the study

You may not qualify if…

• Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, HIV, or stage 1 (one lesion <2 cm) HCC is not exclusion to participation)
• Pregnant or breast feeding
• Received liver transplant
• Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements
• CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria
• History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for 6 months or more. Judgement about chronic alcohol consumption will be made by the site investigator.
• Subject or guardian ability to understand and willingness to provide written consent
• Age greater or equal to 21 years
• Exclusion criteria
• Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past)
• Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.)
• Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation.
• Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days
• If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa.
• Received liver transplant
• Pregnant or breast feeding
• Any of the following laboratory abnormalities within 90 days prior to signing the consent.
• Total bilirubin: >ULN*
• INR: > 1.4
• Healthy Controls
• Inclusion criteria
• AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse)
• Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment
• Ability to understand and willingness to provide written consent.
• Age greater or equal to 21 years

Where it is running

• IU School of Medicine — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University Of Massachusetts — Worcester, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical School — Dallas, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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