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

Completed

• Conditions: Alcoholic Hepatitis

• Registration Number: NCT02172898
• Lead Sponsor: Indiana University

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2018-06-29
• Study Completion: 2019-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Developing a repository of biological samples from AH patients and heavy drinking controls.	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.

Secondary Outcome Measures

Name	Time	Method
Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies.	Up to 1 year

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States