Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02172898

Alcoholic Hepatitis

COMPLETED

Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP

NCT07262515

Acute Alcoholic Hepatitis

RECRUITING

Complex Exploratory Study of Alcohol-Associated Hepatitis

NCT06358196

Alcoholic Hepatitis

NOT_YET_RECRUITING

Characterization of Metabolomic Fingerprints in Patients With Acute Liver Failure and Acute-on-chronic Liver Failure With Hepatic Encephalopathy

NCT05772585

Hepatic Encephalopathy Acute Liver Failure Acute on Chronic Liver Failure

WITHDRAWN

The Liver Care Trial

NCT05855031

Alcoholic Liver Disease Alcohol Use Disorder Alcohol Abuse +3 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The development of new targeted therapies for alcoholic hepatitis (AH) is one of the more urgent needs in clinical hepatology. To reach this goal, large multidisciplinary networks are required. The proposed initiative "Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis" (InTeam) will coordinate a multidisciplinary group composed of clinicians, physician-scientists, basic scientists and bioinformatics experts. The overarching hypothesis of InTeam is that the most rational way to provide a useful framework for future clinical trials in (AH) consists of the (i) determination of key drivers of the disease process, (ii) classification of molecular profiles and subtypes of AH, and (iii) identification of "druggable" targets based on both key drivers and molecular classification. Moreover, mouse models for AH are lacking making it impossible to evaluate promising targets in preclinical mouse studies in a meaningful manner. For this purpose, InTeam will integrate data obtained from molecular pathology studies in human AH and functional studies of key pathways in animal models. The proposed InTeam consortium includes three research projects, ten clinical centers, a Human Biorepository and a Mouse Models Core. The Human Biorepository Core will generate the to-date largest collection of samples from patients with AH from 10 academic liver centers and a comprehensive database that will serve as a basis for the proposed translational studies and be a valuable asset for the broader scientific community. The Mouse Models core will conduct murine studies after establishing and evaluating mouse models of AH based on the pathophysiology and molecular drivers of human AH determined by this consortium.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcoholic Hepatitis Control Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients 18 ≥ and ≤ 70 years of age.
* Active alcohol abuse within the past 3 months.
* Has an Aspartate Aminotransferase (AST) \> Alanine Aminotransferase (ALT).
* Elevated Total Bilirubin level \> 3.0.
* Absence of autoimmune liver disease (ANA\>1/320).
* Absence of hepatitis B infection.
* A liver biopsy, and/or a clinical picture consistent with alcoholic hepatitis.
* The "Start Date" (is the date of the liver biopsy or ≤ to 1 week \[72 hours is preferred\] from the time of admission).

Exclusion Criteria

* Hepatocellular carcinoma.
* Complete portal vein thrombosis.
* Advanced or terminal extrahepatic diseases.
* Lack of consent to participate in the study.
* Pregnancy.
* Received more than 3 days of treatment with (prednisolone or pentoxifyllin) prior to start date.

Control patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No