Alcoholic Hepatitis Network Observational Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03850899|
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : September 22, 2021
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1260 participants|
|Official Title:||Alcoholic Hepatitis Network Observational Study|
|Actual Study Start Date :||April 17, 2019|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||June 2024|
Heavy drinkers with alcoholic hepatitis
Heavy drinkers without significant liver disease
- To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcoholic hepatitis. [ Time Frame: 5 years ]
- To develop a bio-specimen bank comprised of plasma, serum, PBMC, saliva, DNA, urine, stool, liver biopsy and other biological specimens obtained from patients with alcoholic hepatitis, heavy drinkers without clinical liver disease, and healthy subjects. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850899
|United States, Indiana|
|IU School of medicine||Recruiting|
|Indianapolis, Indiana, United States, 46202-2879|
|Contact: Stacy Hyatt, RN 317-274-3263 firstname.lastname@example.org|
|Principal Investigator: Kavish Patidar, DO|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40292|
|Contact: Amar Sutrawe email@example.com|
|Sub-Investigator: Steve Mahanes|
|Principal Investigator: Craig McClain|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ushma Agarwal 617-632-1096 firstname.lastname@example.org|
|Principal Investigator: Gyongi Szabo, MD|
|University Of Massachusetts||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Monique Rinner, RN, MBA 774-442-1982 email@example.com|
|Principal Investigator: Deepika Devuni, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Amy Olofson, BSN 507-284-4531 firstname.lastname@example.org|
|Principal Investigator: Vijay Shah, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Alina Tuladhar 216-445-0688 email@example.com|
|Principal Investigator: Srinivasan Dasarathy, MD|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15260|
|Contact: Ramon Bataller 412-647-1170 BATALLER@pitt.edu|
|Principal Investigator: Ramon Bataller, MD|
|United States, Texas|
|University of Texas Southwestern Medical School||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Leticia Rodriguez 214-648-3352 Leticia.Rodriguez@utsouthwestern.edu|
|Principal Investigator: Mack Mitchell, MD|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23284|
|Contact: Arun Sanyal 804-828-4030 firstname.lastname@example.org|