N/A
N=1,133
Alcoholic Hepatitis Network Observational Study
Alcoholic Hepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03850899 ↗Enrolled (actual)
1,133
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Subjects With Clinical Data Collected — 717; 257; 159 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Clinical Data Collected |
717; 257; 159 | — |
| SECONDARY Number of Subjects With Bio-samples Collected |
698; 247; 159 | — |
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.
Eligibility Criteria
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 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 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 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: 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
Data sourced from ClinicalTrials.gov (NCT03850899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.