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History of Changes for Study: NCT02075918
Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis
Latest version (August 8, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Date Changes
1 February 27, 2014 Nothing (earliest Version on record)
2 September 8, 2014
Recruitment Status
, Study Status and Contacts/Locations
3 June 10, 2015 Study Status
4 February 10, 2016 Study Status
5 September 12, 2016 Study Status and IPDSharing
6 September 13, 2017
Recruitment Status
, Study Status and Contacts/Locations
7 August 8, 2018 Contacts/Locations, Sponsor/Collaborators, Study Status, Eligibility, Oversight and Study Identification
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Changes (Side-by-Side) for Study: NCT02075918
February 27, 2014 (v1) -- August 8, 2018 (v7)

Changes in: Contacts/Locations, Sponsor/Collaborators, Study Status, Eligibility, Oversight, Study Identification and IPDSharing

Study Identification
Unique Protocol ID: 12-2016 12-2016
Brief Title: Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis (InTeam)Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis (InTeam)
Official Title: Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis
Secondary IDs: 1U01AA021908-01 [U.S. NIH Grant/Contract]1U01AA021908-01 [U.S. NIH Grant/Contract]
Study Status
Record Verification: February 2014 August 2018
Overall Status: Unknown status [Previously: Not yet recruiting ] Recruiting
Study Start: March 2014 May 2014
Primary Completion: May 2018 [Anticipated ] May 2019 [Anticipated ]
Study Completion: May 2019 [Anticipated ]
First Submitted: February 27, 2014 February 27, 2014
First Submitted that
Met QC Criteria:
February 27, 2014 February 27, 2014
First Posted: March 3, 2014 [Estimate ] March 3, 2014 [Estimate ]
Last Update Submitted that
Met QC Criteria:
February 27, 2014 August 8, 2018
Last Update Posted: March 3, 2014 [Estimate ] August 10, 2018 [Actual ]
Sponsor/Collaborators
Sponsor: University of North Carolina, Chapel Hill University of Pittsburgh
Responsible Party: Sponsor Principal Investigator
Investigator: Ramon Bataller
Official Title: Professor
Affiliation: University of Pittsburgh
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Wisconsin, Madison
King's College London
Veterans Medical Research Foundation
Hospital Vall d'Hebron
Universidad Autonoma de Nuevo Leon
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Wisconsin, Madison
King's College London
Veterans Medical Research Foundation
Hospital Vall d'Hebron
Institut National de la Santé Et de la Recherche Médicale, France
Yale University
Columbia University
Weill Medical College of Cornell University
University of Alberta
Hospital San Jose Tec de Monterrey
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes Yes
Study Description
Brief Summary: 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. 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.
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. 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
Conditions: Alcoholic Hepatitis Alcoholic Hepatitis
Keywords:
Study Design
Study Type: ObservationalObservational
Observational Study Model: Case-Only Case-Only
Time Perspective: Prospective Prospective
Biospecimen Retention: Samples With DNA Samples With DNA
Biospecimen Description: Serum, Plasma, Whole Blood DNA, PBMCs, Urine, Stool, Liver Biopsy Serum, Plasma, Whole Blood DNA, PBMCs, Urine, Stool, Liver Biopsy
Enrollment: 700 [Anticipated ] 700 [Anticipated ]
Number of Groups/Cohorts 00
Groups and Interventions
Outcome Measures
Primary Outcome Measures:
1. Diagnosis and Severity of Alcoholic Hepatitis
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.

[Time Frame: 3 months after end of Study ]
Diagnosis and Severity of Alcoholic Hepatitis
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.

[Time Frame: 3 months after end of Study ]
Secondary Outcome Measures:
2. Major Liver Complications
As an observational study, we will collect data regarding major liver complications such as, ascites, renal failure, encephalopathy, and bleeding.

[Time Frame: 3 months after end of study ]
Major Liver Complications
As an observational study, we will collect data regarding major liver complications such as, ascites, renal failure, encephalopathy, and bleeding.

[Time Frame: 3 months after end of study ]
3. Death/Transplantation
As an observational study, we will collect the data regarding number the survival of Alcoholic Hepatitis by considering deaths and transplantations.

[Time Frame: 3 months after end of study ]
Death/Transplantation
As an observational study, we will collect the data regarding number the survival of Alcoholic Hepatitis by considering deaths and transplantations.

[Time Frame: 3 months after end of study ]
Eligibility
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. We will prospectively include patients with the following inclusion criteria 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.
Sampling Method: Non-Probability Sample Non-Probability Sample
Minimum Age: 18 Years 18 Years
Maximum Age: 70 Years 70 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  • Patients ≥18 and <70 years of age.
  • Active alcohol abuse defined according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women).
  • Moderate elevation of aminotransferases (usually less than 300 U / L) with a characteristic pattern of AST/ ALT ratio of 2:1.
  • Elevated serum GGT and bilirubin levels.
  • Absence of prior autoimmune liver disease (ANA&lt;1/80, SMA<1/80, LKM1 neg, AMA neg).
  • Absence of hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV neg).
  • Patients with decompensated alcoholic cirrhosis will be suitable for inclusion (eg, acute gastrointestinal bleeding, acute renal failure, hepatic encephalopathy and bacterial infections).
  • Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:
  • Steatosis (either macro or microvesicular).
  • Hepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies).
  • Inflammatory infiltrate (predominantly polymorphonuclear cells).
  • Pericellular or sinusoidal fibrosis.

Exclusion Criteria:

  • Hepatocellular carcinoma.
  • Complete portal vein thrombosis.
  • Advanced or terminal extrahepatic diseases (eg heart failure, advanced lung diseases, advanced oncologic diseases).
  • Lack of consent to participate in the study.
  • Pregnancy.

Inclusion Criteria:

  • Patients 18 ≥ and &#8804; 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&gt;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.
Contacts/Locations
Central Contact: Meritxell Ventura Cotts, MD
Telephone: 1(412) 383-4242
Email: MVENTURA@pitt.edu
Central Contact Backup: Ramon Bataller, MD
Telephone: (919) 966-4812
Email: ramon_bataller@med.unc.edu
Ramon Bataller
Telephone: 1(412)3834241
Study Officials: Ramon Bataller, MD
Principal Investigator
University of North Carolina, Chapel Hill
Ramon Bataller, MD
Principal Investigator
University of Pittsburgh
Locations: United States, North CarolinaUnited States, Pennsylvania
University of North Carolina at Chapel Hill
[Not yet recruiting]
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Ramon Bataller, MD
University of Pittsburgh
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15212
Contact: Meritxell Ventura Cotts, MD 412-383-4242 rimerck@upmc.edu
Contact: Carole Rimer 412 383-4242 rimerck@upmc.edu
Principal Investigator: Ramon Bataller, MD
IPDSharing
Plan to Share IPD: No
References
Citations:
Links:
Available IPD/Information:

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