Alcoholic HepatitisInTeamNCT02075918
Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis
An observational study of Alcoholic Hepatitis and Control Patients, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Hepatitis, Control Patients
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15212
About this study
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.
Read the 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.
- Conditions
- Alcoholic Hepatitis, Control Patients
- Medical subject headings
- Hepatitis, Alcoholic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after end of Study
Secondary outcomes (2)
Major Liver Complications
As an observational study, we will collect data regarding major liver complications such as, ascites, renal failure, encephalopathy, and bleeding.
Measured: 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.
Measured: 3 months after end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- 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, Institut National de la Santé Et de la Recherche Médicale, France, Yale University, Columbia University, Weill Medical College of Cornell University, University of Alberta, TecSalud Investigación Clínica
- Responsible party
- Principal investigator, Ramon Bataller, University of Pittsburgh
- Investigators
- Ramon Bataller, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075918
- Sponsor's protocol ID
- 12-2016
- Other IDs
- 1U01AA021908-01
- Acronym
- InTeam
- Status last verified
- Jun 2019
- First submitted
- 27 Feb 2014
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lang S, Duan Y, Liu J, Torralba MG, Kuelbs C, Ventura-Cots M, Abraldes JG, Bosques-Padilla F, Verna EC, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross D, Lucey MR, Louvet A, Mathurin P, Garcia-Tsao G, Ho SB, Tu XM, Bataller R, Starkel P, Fouts DE, Schnabl B. Intestinal Fungal Dysbiosis and Systemic Immune Response to Fungi in Patients With Alcoholic Hepatitis. Hepatology. 2020 Feb;71(2):522-538. doi: 10.1002/hep.30832. Epub 2019 Aug 20.
PubMed 31228214
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02075918
- Acronym / sponsor ID
- InTeam / 12-2016
- Conditions
- Alcoholic Hepatitis, Control Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- 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, Institut National de la Santé Et de la Recherche Médicale, France, Yale University, Columbia University, Weill Medical College of Cornell University, University of Alberta, TecSalud Investigación Clínica
- Study start
- May 2014
- Primary completion
- May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (7 listed)
- Hepatocellular carcinoma.
- Complete portal vein thrombosis.
- Advanced or terminal extrahepatic diseases.
- Lack of consent to participate in the study.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Major Liver Complications
Time frame: 3 months after end of study
Death/Transplantation
Time frame: 3 months after end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 31228214Lang S, Duan Y, Liu J, Torralba MG, Kuelbs C, Ventura-Cots M, Abraldes JG, Bosques-Padilla F, Verna EC, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross D, Lucey MR, Louvet A, Mathurin P, Garcia-Tsao G, Ho SB, Tu XM, Bataller R, Starkel P, Fouts DE, Schnabl B. Intestinal Fungal Dysbiosis and Systemic Immune Response to Fungi in Patients With Alcoholic Hepatitis. Hepatology. 2020 Feb;71(2):522-538. doi: 10.1002/hep.30832. Epub 2019 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon Bataller, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Hepatitis and Control Patients, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis and Severity of Alcoholic Hepatitis (time frame: 3 months after end of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.