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Alcoholic Hepatitis Network Observational Study

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: NCT03850899
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : October 20, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Samer Gawrieh, Indiana University

Study Description
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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.


Condition or disease
Alcoholic Hepatitis

Detailed Description:

What should I know about this research?

  • Someone will explain this research to you.
  • Taking part in this research is voluntary. Whether you take part is up to you.
  • If you don't take part, it won't be held against you.
  • You can take part now and later drop out, and it won't be held against you
  • If you don't understand, ask questions.
  • Ask all the questions you want before you decide.

How long will I be in this research? We expect that your taking part in this research will last up to 6 months, after the 6 months we will look in your medical records every 180 days for up to five years.

Why is this research being done? The purpose of this research is to create a clinical database and bio-repository to study alcoholic hepatitis.

What happens to me if I agree to take part in this research? If you decide to take part in this research study, the general procedures include: 1) allowing the investigators to review your medical records, 2) answering questions about you and your health, 3) completing questionnaires about alcohol use, 4) having a physical exam and blood drawn, and 5) providing urine and stool samples.

Could being in this research hurt me? The most important risks or discomforts that you may expect from taking part in this research include mild pain from blood draws and a small chance for a loss of confidentiality (e.g., unauthorized users gain access to sensitive and protected data about you).

Will being in this research benefit me? It is not expected that you will personally benefit from this research. Possible benefits to others may include understanding specific health conditions in patients with alcoholic hepatitis or other diseases.

Study Design
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Study Type : Observational
Estimated Enrollment : 1260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alcoholic Hepatitis Network Observational Study
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Cases
Heavy drinkers with alcoholic hepatitis
Controls
Heavy drinkers without significant liver disease
Donor
Healthy non-drinkers


Outcome Measures
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Primary Outcome Measures :
  1. To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcoholic hepatitis. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To develop a bio-specimen bank comprised of plasma, serum, PBMC, saliva, DNA, urine, stool, liver biopsy and other biological specimens obtained from patients with alcoholic hepatitis, heavy drinkers without clinical liver disease, and healthy subjects. [ Time Frame: 5 years ]

Eligibility Criteria
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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.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Any subject with Alcoholic hepatitis, Heavy healthy drinkers, and Healthy controls
Criteria

CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

  1. A clinical diagnosis of alcoholic hepatitis as defined by the NIAAA pan-consortia for AH:

    1. Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit
    2. 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
    3. AST > 50 IU/l
    4. AST:ALT > 1.5 and both values < 400 IU/l
    5. and/or histological evidence of AH*
  2. Serum total bilirubin >3 mg/dL
  3. Subject or guardian ability to understand and willingness to provide written consent
  4. Age greater or equal to 21 years
  5. 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

Exclusion criteria

  1. 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)
  2. Pregnant or breast feeding
  3. Received liver transplant
  4. 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

  1. 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.
  2. Subject or guardian ability to understand and willingness to provide written consent
  3. Age greater or equal to 21 years

Exclusion criteria

  1. 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)

  2. 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.

  3. 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
  4. 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.
  5. Received liver transplant
  6. Pregnant or breast feeding

  7. Any of the following laboratory abnormalities within 90 days prior to signing the consent.

    1. Total bilirubin: >ULN*
    2. INR: > 1.4

Healthy Controls

Inclusion criteria

  1. AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse)
  2. Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment
  3. Ability to understand and willingness to provide written consent.
  4. Age greater or equal to 21 years

Exclusion criteria

  1. Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcoholic hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B.
  2. Presence of diabetes (requiring treatment with oral agents or insulin).
  3. Significant heart disease (prior history of heart disease, other than hypertension)
  4. Chronic lung disease (requiring chronic treatment)
  5. Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.)
  6. Known infection with HIV
  7. Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days
  8. BMI>35
  9. Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
  10. Received liver transplant
  11. Pregnant or breast feeding

  12. Any of the following laboratory abnormalities within 90 days prior to signing the consent.

    1. Hemoglobin: <10 g/dL
    2. Conjugated bilirubin: > ULN
    3. INR: > 1.4
    4. AST: >40 IU/mL
    5. ALT: >40 IU/mL
  13. Based on the judgment of the investigator, subject is not capable of complying with the study requirements
Contacts and Locations
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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): NCT03850899


Contacts
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Contact: Savannah Yarnelle 317-278-6424 samussel@iu.edu

Locations
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United States, Indiana
IU School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202-2879
Contact: Kavish Patidar, DO    317-278-9246    kpatidar@iu.edu   
Principal Investigator: Kavish Patidar, DO         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Ryne Bruner    502-852-7402    ryne.bruner@louisville.edu   
Sub-Investigator: Steve Mahanes         
Principal Investigator: Craig McClain         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ushma Agarwal    617-632-1096    uagarwal@bidmc.harvard.edu   
Principal Investigator: Gyongi Szabo, MD         
University Of Massachusetts Terminated
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Amy Olofson, BSN    507-284-4531    olofson.amy@mayo.edu   
Principal Investigator: Vijay Shah, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sugapradha Saravanan    216-445-0688    SARAVAS2@ccf.org   
Principal Investigator: Srinivasan Dasarathy, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Jaideep Behari    412-647-1170    behajx@upmc.edu   
Principal Investigator: Jaideep Behari, MD         
United States, Texas
University of Texas Southwestern Medical School Recruiting
Dallas, Texas, United States, 75390
Contact: Leticia Rodriguez    214-648-3352    Leticia.Rodriguez@utsouthwestern.edu   
Principal Investigator: Mack Mitchell, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Contact: Arun Sanyal    804-828-4030    arun.sanyal@vcuhealth.org   
Sponsors and Collaborators
Indiana University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information
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Responsible Party: Samer Gawrieh, Co-Director, Alcoholic Hepatitis Network Data Coordinating Center and Associate Professor of Medicine Division of Gastroenterology and Hepatology, Indiana University
ClinicalTrials.gov Identifier: NCT03850899    
Other Study ID Numbers: AlcHepNet-01
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders