ALCOHOLIC HEPATITIS NETWORK OBSERVATIONAL STUDY
The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, 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.
Prospective, observational study
Indiana University; University of Louisville affiliated hospitals in Kentucky; University of Massachusetts Medical Center in Massachusetts; Mayo Clinic in Rochester, Minnesota; Cleveland Clinic Foundation, Ohio; University of Pittsburgh Medical Center in Pennsylvania; University of Texas at Southwestern in Dallas, Texas; and Virginia Commonwealth University in Richmond, Virginia
Planned Number of Patients
Approximately 1260 (720 subjects with alcoholic hepatitis (AH), 360 heavy drinkers without AH, and 180 healthy donors) will be enrolled.
PRIMARY OBJECTIVE: To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcoholic hepatitis.
SECONDARY OBJECTIVE: To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcoholic hepatitis, heavy drinkers without clinical liver disease, and healthy subjects to support translational research in the pathophysiology of alcoholic hepatitis
Screening phase: Subjects will be assessed for the eligibility criteria and a written informed consent will be obtained from the eligible subjects.
Study phase: Subjects will undergo history taking, physical examination, questionnaire administration, and laboratory tests. Biosamples including serum/plasma, peripheral mononuclear cells (at select sites), genomic DNA, stool samples (when available), urine, and liver tissue (where available) will be obtained.
Follow up phase: Alcoholic hepatitis subjects will be followed for 360 days, Heavy drinking controls for 180 days, and healthy controls subjects for 1 day (at initial meeting for baseline).
AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH.