Clinical Trial: Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Brief Summary: 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.

Detailed Summary:
Sponsor: Indiana University

Current Primary Outcome: Developing a repository of biological samples from AH patients and heavy drinking controls. [ Time Frame: Up to 1 year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies. [ Time Frame: Up to 1 year ]

Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: June 9, 2014
Date Started: June 2013
Date Completion: December 2018
Last Updated: November 4, 2016
Last Verified: November 2016