An observational study in Alcoholic Hepatitis, sponsored by Indiana University. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Indiana University · Observational
To conduct a prospective, multicenter, observational study of patients with well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository will be developed from both cases and controls.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 454 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Individuals with AH and suitable controls will be enrolled at Indiana University and affiliated hospitals. In addition, the enrollment will be conducted simultaneously at Mayo Clinic and Virginia Commonwealth University with the same target enrollment.
CASES: Heavy drinkers with alcoholic hepatitis
Inclusion criteria
Exclusion criteria
CONTROLS: Heavy drinkers without alcoholic hepatitis
Inclusion criteria
Exclusion criteria
Heavy alcohol drinking will be defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment. Heavy drinkers, who have just become abstinent within prior 2 weeks, including those we convince to seek treatment as part of the recruiting process, are eligible for enrollment. Control subjects must meet the following criteria: (1) AST, ALT, and total bilirubin levels must be within normal range; (2) no prior history of known alcoholic liver disease; and (3) absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
Diagnosis of AH will be established on published criteria based on history of heavy alcohol consumption (defined as \> 40 grams per day on average in women and \> 60 grams per day on average for men for a minimum of 6 months and within the 6 weeks prior to study enrollment), clinical evaluation and appropriate laboratory testing (as defined as total bilirubin \> 2 mg/dL and AST \> 50 U/L). When diagnosis of AH remains in question, a liver biopsy (if clinically feasible and subject has no contraindications) will be required. We plan to enroll patients with AH in special population infected with hepatitis B (HBV), hepatitis C (HCV), or HIV.
Developing a repository of biological samples from AH patients and heavy drinking controls.
To conduct a prospective, multicenter, observational study of patients with well-characterized AH and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository of serum/plasma, peripheral mononuclear cells, genomic DNA, stool samples, urine, and liver tissue (where available) will be developed from both cases and controls.
Time frame: Up to 1 year
Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies.
Time frame: Up to 1 year
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Indiana University