Status:
COMPLETED
Alcoholic Hepatitis Network Observational Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
21+ years
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 healt...
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'...
Eligibility Criteria
Inclusion
- CASES: Heavy drinkers with alcoholic hepatitis
- Inclusion criteria
- 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
- Exclusion criteria
- 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
- Exclusion criteria
- 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.
- Presence of diabetes (requiring treatment with oral agents or insulin).
- Significant heart disease (prior history of heart disease, other than hypertension)
- Chronic lung disease (requiring chronic treatment)
- Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.)
- Known infection with HIV
- Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days
- BMI\>35
- 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
- Received liver transplant
- Pregnant or breast feeding
- Any of the following laboratory abnormalities within 90 days prior to signing the consent.
- Hemoglobin: \<10 g/dL
- Conjugated bilirubin: \> ULN
- INR: \> 1.4
- AST: \>40 IU/mL
- ALT: \>40 IU/mL
- Based on the judgment of the investigator, subject is not capable of complying with the study requirements
Exclusion
Key Trial Info
Start Date :
April 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
1133 Patients enrolled
Trial Details
Trial ID
NCT03850899
Start Date
April 17 2019
End Date
June 21 2024
Last Update
February 14 2025
Active Locations (9)
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1
IU School of Medicine
Indianapolis, Indiana, United States, 46202-2879
2
University of Louisville
Louisville, Kentucky, United States, 40292
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
University Of Massachusetts
Worcester, Massachusetts, United States, 01655