Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis (InTeam)

June 5, 2019 updated by: Ramon Bataller, University of Pittsburgh
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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an episode of alcoholic hepatitis fulfilling the inclusion criteria will be eligible to participate in the study. Those patients who meet one or more exclusion criteria will not be included.

Control patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis and Severity of Alcoholic Hepatitis
Time Frame: 3 months after end of Study
Utilizing liver tissue, blood samples, and stool and urine samples, InTeam will aim to discover and validate factors associated with the diagnosis and severity of Alcoholic hepatitis.
3 months after end of Study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Liver Complications
Time Frame: 3 months after end of study
As an observational study, we will collect data regarding major liver complications such as, ascites, renal failure, encephalopathy, and bleeding.
3 months after end of study
Death/Transplantation
Time Frame: 3 months after end of study
As an observational study, we will collect the data regarding number the survival of Alcoholic Hepatitis by considering deaths and transplantations.
3 months after end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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