- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075918
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
Conditions
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
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- University of Pittsburgh
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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.
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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.
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3 months after end of study
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Death/Transplantation
Time Frame: 3 months after end of study
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As an observational study, we will collect the data regarding number the survival of Alcoholic Hepatitis by considering deaths and transplantations.
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3 months after end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ramon Bataller, MD, University of Pittsburgh
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
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Liver Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Hepatitis
- Hepatitis A
- Hepatitis, Alcoholic
Other Study ID Numbers
- 12-2016
- 1U01AA021908-01 (U.S. NIH Grant/Contract)
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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