Alcoholic Hepatitis
Conditions
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.
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.
Interventions
None listed
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Indiana University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Clinical Data Collected | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With Bio-samples Collected | 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases Heavy drinkers with alcoholic hepatitis | 717 |
| Controls Heavy drinkers without significant liver disease | 257 |
| Donor Healthy non-drinkers | 159 |
| Total | 1,133 |
Baseline characteristics
| Characteristic | Cases | Controls | Donor | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 28 Participants | 3 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 694 Participants | 229 Participants | 156 Participants | 1079 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 7 Participants | 16 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 638 Participants | 247 Participants | 140 Participants | 1025 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 3 Participants | 3 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 5 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 27 Participants | 31 Participants |
| Race (NIH/OMB) Black or African American | 82 Participants | 64 Participants | 18 Participants | 164 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 2 Participants | 9 Participants | 31 Participants |
| Race (NIH/OMB) White | 601 Participants | 183 Participants | 101 Participants | 885 Participants |
| Region of Enrollment United States | 717 participants | 257 participants | 159 participants | 1133 participants |
| Sex: Female, Male Female | 294 Participants | 109 Participants | 99 Participants | 502 Participants |
| Sex: Female, Male Male | 423 Participants | 148 Participants | 60 Participants | 631 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 194 / 717 | 4 / 257 | 0 / 159 |
| other Total, other adverse events | 0 / 717 | 0 / 257 | 0 / 159 |
| serious Total, serious adverse events | 0 / 717 | 0 / 257 | 0 / 159 |
Outcome results
Primary
Number of Subjects With Clinical Data Collected
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Subjects With Clinical Data Collected | 717 Participants |
| Controls | Number of Subjects With Clinical Data Collected | 257 Participants |
| Donor | Number of Subjects With Clinical Data Collected | 159 Participants |
Secondary
Number of Subjects With Bio-samples Collected
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Subjects With Bio-samples Collected | 698 Participants |
| Controls | Number of Subjects With Bio-samples Collected | 247 Participants |
| Donor | Number of Subjects With Bio-samples Collected | 159 Participants |