Alcoholic Hepatitis Network Observational Study

NCT03850899 | Completed Results DMC

• 1 other identifier: AlcHepNet-01
• Study Type: observational
• Target: 1,133
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Clinical Data Collected

  5 years

Secondary Outcomes (1)

• Number of Subjects With Bio-samples Collected

  5 years

Study Arms (3)

Cases

Heavy drinkers with alcoholic hepatitis

Controls

Heavy drinkers without significant liver disease

Donor

Healthy non-drinkers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any subject with Alcoholic hepatitis, Heavy healthy drinkers, and Healthy controls

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:

• 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
• 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
• 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)
• \*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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (9)

IU School of Medicine

Indianapolis, Indiana, 46202-2879, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University Of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas Southwestern Medical School

Dallas, Texas, 75390, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (1)

• Dasarathy S, Tu W, Bellar A, Welch N, Kettler C, Tang Q, Liangpunsakul S, Gawrieh S, Radaeva S, Mitchell M; AlcHepNet. Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the AlcHep Network. Contemp Clin Trials. 2024 Mar;138:107437. doi: 10.1016/j.cct.2024.107437. Epub 2024 Jan 11.

  PMID: 38215876 DERIVED

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Samer Gawrieh
• Organization: Indiana University School of Medicine

sgawrieh@iu.edu

(317) 278-9326

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Alcoholic Hepatitis Network Data Coordinating Center and Associate Professor of Medicine Division of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: April 17, 2019
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: February 14, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)