Alcoholic Liver DiseaseInLiNCT03915002
Integrated Approaches for Identifying Molecular Targets in Liver Disease
An observational study of Alcoholic Liver Disease and Non-Alcoholic Fatty Liver Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
To provide a framework for successful clinical trials testing novel targets for therapy in liver disease. To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease, Steatohepatitis, Nonalcoholic
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 12 Apr 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Alcoholic Steatohepatitis and Alcoholic liver disease 2. Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH)
Who may be able to join
- Patients with a previous probable or possible AH episode will be defined following the guidelines proposed by the NIAAA.
- Patients with a diagnosis of cirrhosis due to alcohol related liver disease according to clinical and/or analytic and/or radiological criteria.
- Patients diagnosed with an alcohol use disorder identification test (AUDIT) total scores of 8 or more OR Patients with a score lower than 8 in the AUDIT test but for whom there is a high suspicion of current or recent (within one year) AUD based on medical history, self reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, or alcohol induced organ involvement other than decompensated liver disease.
- Patients who admit having a persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men.
- Any stage of liver disease: from simple elevation of transaminases to any METAVIR or Ishack score assess by liver biopsy or by any validated noninvasive fibrosis score.
- Patients without a preexistent liver fibrosis assessment for whom there is a high suspicion of liver disease according to clinical and/or analytic and/or radiological criteria will also be included.
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- Patients with a biopsy proven steatosis or steatosis and mild lobular inflammation OR Patients without a biopsy but with a high suspicious of NAFL and with at least three of the next 5 components of metabolic syndrome. (Waist circumference≥102/≥88 cm (40/35 inches) for men/women, Arterial pressure≥130/85mmHg or treated for hypertension, Fasting glucose 100mg/dl (5.6mmol/L) or treated for Type 2 diabetes, Serum triglyceride (triacylglycerols)>150mg/dL (>1.7mmol/L) if available, HDL cholesterol <40/50mg/dl for men/women (<1/<1.3 mmol/L) if available)
- Patients with a biopsy proven NASH and Metavir fibrosis score (or equivalent score) of F0-F2 OR Patients without a biopsy but with a high suspicious of NASH, with at least three of the next 5 components of metabolic syndrome and with a validated noninvasive score of F0-F2. (Waistcircumference≥102/≥88 cm (40/35 inches) for men/women, Arterial pressure≥130/85mmHg or treated for hypertension, Fasting glucose 100mg/dl (5.6mmol/L) or treated for Type 2 diabetes, Serum triglyceride (triacylglycerols) >150mg/dL (>1.7mmol/L) if available, HDL cholesterol <40/50mg/dl for men/women (<1/<1.3 mmol/L) if available)
- Patients with a biopsyproven NASH and a METAVIR fibrosis score (or equivalent score) of F3-F4 OR Patients without a biopsy proven but with a high suspicious of NASH, with at least three of the next 5 components of metabolic syndrome and with a validated noninvasive fibrosis test score of F2-F3. (Waist circumference≥102/≥88 cm (40/35 inches) for men/women, Arterial pressure≥130/85mmHg or treated for hypertension, Fasting glucose 100mg/dl (5.6mmol/L) or treated for Type 2 diabetes, Serum triglyceride (triacylglycerols)>150mg/dL (>1.7mmol/L) if available, HDL cholesterol <40/50mg/dl for men/women (<1/<1.3 mmol/L) if available)
- Patients diagnosed with an alcohol use disorder identification test (AUDIT) total scores of 8 or more or Patients with a score lower than 8 in the AUDIT test but for whom there is a high suspicion of current or recent (within one year) AUD based on medical history, self reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, or alcohol induced organ involvement other than decompensated liver disease.
- Patients who admit having a persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men.
- At least three of the next 5 components of metabolic syndrome (Waist circumference≥102/≥88 cm (40/35 inches) for men/women, Arterial pressure≥130/85mmHg or treated for hypertension, Fasting glucose 100mg/dl (5.6mmol/L) or treated Type 2 diabetes, Serum triglyceride (triacylglycerols)>150mg/dL (>1.7mmol/L), HDL <40/50mg/dl for men/women (<1/<1.3 mmol/L).)
- BMI≥30
- Any stage of liver disease: from simple elevation of transaminases to any METAVIR orIshack score assess by liver biopsy or by any validated noninvasive methods.
- Patients without a preexistent liver fibrosis assessment for whom there is a high suspicion of liver disease according to clinical and/or analytic and/or radiological criteria will also be included.
Who cannot join
- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular
- carcinoma).
- Patients who are pregnant or breastfeeding.
- Complete portal vein thrombosis (PVT).
- Previous liver transplant recipient
- Patients with cirrhosis due to alcohol related liver disease without AH with or without a prior episode of decompensation.
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- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
- Patients who are pregnant or breastfeeding.
- Complete portal vein thrombosis
- Previous liver transplant recipient
- Current alcoholic hepatitis episode
- Alcoholic liver disease with compensated never decompensated liver disease.
- Patients with a past history of decompensated advanced liver disease (i.e. jaundice episodes, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known hepatocellular carcinoma.
- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
- Patients who are pregnant or breastfeeding.
- Non-Alcoholic Fatty Liver (NAFL)
- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
- Patients who are pregnant or breastfeeding.
- Complete portal vein thrombosis
- Alcohol intake of more than 20g/daily.
- Absence of other possible diagnoses (HCV and HBV negative, ANA's < 1:160, ASMA <1:80)
- Patients with compensated early NASH.
- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
- Patients who are pregnant or breastfeeding.
- Complete portal vein thrombosis.
- Alcohol intake of more than 20g/daily.
- Absence of other possible diagnoses (HCV and HBV negative, ANA's < 1:160, ASMA <1:80).
- Decompensated liver diseases.
- Patients with NASH advance fibrosis or cirrhosis compensated or decompensated.
- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
- Patients who are pregnant or breastfeeding.
- Complete portal vein thrombosis.
- Alcohol intake of more than 20g/daily.
- Absence of other possible diagnoses (HCV and HBV negative, ANA's < 1:160, ASMA < 1:80).
- Dual NonAlcoholic Fatty Liver Disease and Alcoholic fatty liver disease (DAFLD) compensated or decompensated.
- Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
- Patients who are pregnant or breastfeeding.
- Complete portal vein thrombosis.
- Absence of other possible diagnoses (HCV and HBV negative, ANA's < 1:160, ASMA < 1:80).
- A probable or possible episode of Alcoholic Hepatitis as defined by the NIAAA guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical center
Pittsburgh, Pennsylvania, 15213
About this study
To provide a framework for successful clinical trials testing novel targets for therapy in liver disease.
To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression.
Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.
Read the detailed description
In 2015, chronic liver diseases were responsible for approximately 2% of worldwide mortality and in 2016 cirrhosis and chronic liver diseases accounted for 531.1 age- standardized, Disability Adjusted Life Years (DALY's) /100,000 habitants.(1, 2) Cirrhosis is a leading cause of death worldwide within adults between 50 and 70 years old. In the past few decades vast improvements have been made, death rates have decreased for almost all diseases. However, in the USA, the occurrence of alcoholic cirrhosis and HCV cirrhosis has increased, 79 and 75% respectively, from 1990 to 2016 in regards of total number of deaths (3). This trend can also be observed in other countries such as UK where standardized mortality rates have increased 400% in the last 44 years. This has a big impact in the working-age population (18-65 years old)(4). The main causes of liver cirrhosis are hepatitis B virus (HBV) and C (HCV) as well as alcoholic and non-alcoholic fatty liver disease (ALD and NAFLD, respectively).
Most chronic liver diseases have a silent course until the development of complications. For patients with compensated disease, the presence of significant liver fibrosis predicts decompensated disease and early mortality.(5-8) Therefore, diagnosis at early stages is mandatory to prevent liver-related morbidity and mortality.
The aim of this project is to provide a framework for successful clinical trials testing novel targets for therapy in liver disease. The "Integrated Approaches for Identifying Molecular Targets in Liver Disease" (InLi) group is aimed to fill this gap. The group InLi will be composed of a multidisciplinary group including hepatologists, physician-scientists, basic scientists and bioinformatics experts. The main goal of InLi is to provide a framework for successful clinical trials testing novel targets for therapy in alcoholic hepatitis. The Human Biorepository Core will include a variety of biological samples from patients with a wide arrange of liver diseases as well as healthy controls from UPMC liver center as well as a comprehensive database that includes epidemiological, dietary, anthropometrical, analytical, histological, and clinical data.
A common protocol for tissue processing, shipping and storage will be used to ensure sample integrity and quality. Storage of data generated from patients and biospecimens will be facilitated through, Research Electronic Data Capture (REDCap) system, and will follow strict security measures including encryption, coding and limited access to the database.
The development of new-targeted therapies for most liver diseases, but especially, steatohepatitis, one of the more urgent needs in clinical hepatology. To reach this goal, a large multidisciplinary network is required. InLI coordinates a multidisciplinary group composed of clinicians, physician-scientists, basic scientists and bioinformatics experts. The overarching hypothesis of InLi is that the most rational way to provide a useful framework for future clinical trials in liver disease consists of the (i) determination of key drivers of the disease process, (ii) classification of molecular profiles and subtypes of specific liver diseases within each and every pathology, and (iii)identification of "druggable" targets based on both key drivers and molecular classification.
The Human Biorepository Core will generate a large collection of samples from patients with different Liver diseases (e.g. viral, steatohepatitis and cholestasis liver disease). For each disease, we will consider a range of phenotypes focusing in early, intermediate and late disease stages and for each etiology. Moreover, we will also include samples from control patients. We will also build 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 two scientific projects will combine a thorough molecular characterization of patients with different liver disease with studies on key and targetable pathways that drive key aspects of alcoholic hepatitis (AH) disease progression and outcome such as inflammation, injury and regeneration.
Project 1: ("Molecular Subtypes for Targeted Therapies in Liver disease") will identify molecular and cellular drivers of liver disease to provide a molecular classification using RNA sequencing, kinomic, metabolomic and novel systems biology approaches, and determine contributors to unfavorable outcomes and the associated progenitor cell accumulation.
Project 2: ("Determination of key drivers of the disease progression") The aim of the study is to describe histological, clinical and molecular characteristics that will make a particular disease evolve from early to advance form. We will use "omics" and novel systems, a biological approach as well as classic immunohistochemistry and histology stain technics. We will also use different imaging methodologies including second harmonic generation imaging microscopy (SHIM) and electronic microscopy to describe and identify specific histological patterns.
Project 3: Build a Human repository capable of providing a platform to develop projects 1 and 2.
- Conditions
- Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease, Steatohepatitis, Nonalcoholic, Steatohepatitis
- Medical subject headings
- Liver Diseases, Alcoholic, Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Steatohepatitis: 1. Alcoholic Steatohepatitis and Alcoholic liver disease 2. Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) | |
| Disease control | Patients 18 years or older with a diagnosis of cholestatic liver diseases (primary biliary cholangitis or primary sclerosing cholangitis) or hepatotropic virus (hepatitis C or B virus), according to the current international guidelines. | |
| Control subjects | Patients over 18 years old without a diagnosis of liver disease that for any other reason (i.e candidate to liver donor, patients with liver metastasis that require surgery, patients with any type of benign liver tumor or HCC in a healthy liver). Patient over 18 years old with a documented alcoholic used disorder in their clinical records and without any evidence of liver disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Subtypes for Targeted Therapies in Liver disease
- Generation of consistent non-invasive molecular footprints of disease severity and prognosis: plasma and peripheral blood cells from groups of patients with different disease prognosis will be analyzed by means of high throughput proteomics (Mass Spectrometry and aptamer mediated identification) and single cell RNA sequencing, respectively. Data will be integrated with liver RNA-sequencing to detect relevant liver fingerprints in plasma.
- Mechanisms of ductular reaction and hepatocyte de-differentiation will be studied by micro-dissection and region-specific RNA-sequencing.
- Mechanisms of hepatocyte dedifferentiation will be evaluated using methylation bead chip and chromatin immunoprecipitation coupled to DNA sequencing (ChIP-seq) of histone marks related with activation, enhancement, poisoning and repression of gene expression.
Measured: 5 years
Determination of key drivers of the disease progression
- To describe and identified the histological patters in each phase of the disease (using imaging technics, including second harmonic generation imaging microscopy and electronic microscopy as well as classical IHC technics)
- To quantified and compare the degree of hepatic steatosis and fibrosis assessed by non-invasive techniques such as FibroScan® (CAP controlled attenuation parameter) across different cohorts of patients and across the different stages of the disease within the same patient's phenotype.
- To identify the main genetic. psychosocial, and environmental factors influencing the development of advanced liver fibrosis among patients with known or suspected excessive alcohol intake. Through DNA
Measured: 5-10 years
repository capable of providing a framework fro the other outcomes
To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcoholic hepatitis, control disease and healthy controls
Measured: 2-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start13 Jun 2019
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gavin Arteel, University of Pittsburgh
- Investigators
- Jaideep Behari, MD, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915002
- Sponsor's protocol ID
- STUDY19120198
- Acronym
- InLi
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Approaches for Identifying Molecular Targets in Liver Disease
- ClinicalTrials.gov ID
- NCT03915002
- Acronym / sponsor ID
- InLi / STUDY19120198
- Conditions
- Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease, Steatohepatitis, Nonalcoholic, Steatohepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
To provide a framework for successful clinical trials testing novel targets for therapy in liver disease.
To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression.
Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.
Detailed description
In 2015, chronic liver diseases were responsible for approximately 2% of worldwide mortality and in 2016 cirrhosis and chronic liver diseases accounted for 531.1 age- standardized, Disability Adjusted Life Years (DALY's) /100,000 habitants.(1, 2) Cirrhosis is a leading cause of death worldwide within adults between 50 and 70 years old. In the past few decades vast improvements have been made, death rates have decreased for almost all diseases. However, in the USA, the occurrence of alcoholic cirrhosis and HCV cirrhosis has increased, 79 and 75% respectively, from 1990 to 2016 in regards of total number of deaths (3). This trend can also be observed in other countries such as UK where standardized mortality rates have increased 400% in the last 44 years. This has a big impact in the working-age population (18-65 years old)(4). The main causes of liver cirrhosis are hepatitis B virus (HBV) and C (HCV) as well as alcoholic and non-alcoholic fatty liver disease (ALD and NAFLD, respectively).
Most chronic liver diseases have a silent course until the development of complications. For patients with compensated disease, the presence of significant liver fibrosis predicts decompensated disease and early mortality.(5-8) Therefore, diagnosis at early stages is mandatory to prevent liver-related morbidity and mortality.
The aim of this project is to provide a framework for successful clinical trials testing novel targets for therapy in liver disease. The "Integrated Approaches for Identifying Molecular Targets in Liver Disease" (InLi) group is aimed to fill this gap. The group InLi will be composed of a multidisciplinary group including hepatologists, physician-scientists, basic scientists and bioinformatics experts. The main goal of InLi is to provide a framework for successful clinical trials testing novel targets for therapy in alcoholic hepatitis. The Human Biorepository Core will include a variety of biological samples from patients with a wide arrange of liver diseases as well as healthy controls from UPMC liver center as well as a comprehensive database that includes epidemiological, dietary, anthropometrical, analytical, histological, and clinical data.
A common protocol for tissue processing, shipping and storage will be used to ensure sample integrity and quality. Storage of data generated from patients and biospecimens will be facilitated through, Research Electronic Data Capture (REDCap) system, and will follow strict security measures including encryption, coding and limited access to the database.
The development of new-targeted therapies for most liver diseases, but especially, steatohepatitis, one of the more urgent needs in clinical hepatology. To reach this goal, a large multidisciplinary network is required. InLI coordinates a multidisciplinary group composed of clinicians, physician-scientists, basic scientists and bioinformatics experts. The overarching hypothesis of InLi is that the most rational way to provide a useful framework for future clinical trials in liver disease consists of the (i) determination of key drivers of the disease process, (ii) classification of molecular profiles and subtypes of specific liver diseases within each and every pathology, and (iii)identification of "druggable" targets based on both key drivers and molecular classification.
The Human Biorepository Core will generate a large collection of samples from patients with different Liver diseases (e.g. viral, steatohepatitis and cholestasis liver disease). For each disease, we will consider a range of phenotypes focusing in early, intermediate and late disease stages and for each etiology. Moreover, we will also include samples from control patients. We will also build 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 two scientific projects will combine a thorough molecular characterization of patients with different liver disease with studies on key and targetable pathways that drive key aspects of alcoholic hepatitis (AH) disease progression and outcome such as inflammation, injury and regeneration.
Project 1: ("Molecular Subtypes for Targeted Therapies in Liver disease") will identify molecular and cellular drivers of liver disease to provide a molecular classification using RNA sequencing, kinomic, metabolomic and novel systems biology approaches, and determine contributors to unfavorable outcomes and the associated progenitor cell accumulation.
Project 2: ("Determination of key drivers of the disease progression") The aim of the study is to describe histological, clinical and molecular characteristics that will make a particular disease evolve from early to advance form. We will use "omics" and novel systems, a biological approach as well as classic immunohistochemistry and histology stain technics. We will also use different imaging methodologies including second harmonic generation imaging microscopy (SHIM) and electronic microscopy to describe and identify specific histological patterns.
Project 3: Build a Human repository capable of providing a platform to develop projects 1 and 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Steatohepatitis: 1. Alcoholic Steatohepatitis and Alcoholic liver disease 2. Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) |
| Disease control | – | –Patients 18 years or older with a diagnosis of cholestatic liver diseases (primary biliary cholangitis or primary sclerosing cholangitis) or hepatotropic virus (hepatitis C or B virus), according to the current international guidelines. |
| Control subjects | – | –Patients over 18 years old without a diagnosis of liver disease that for any other reason (i.e candidate to liver donor, patients with liver metastasis that require surgery, patients with any type of benign liver tumor or HCC in a healthy liver). Patient over 18 years old with a documented alcoholic used disorder in their clinical records and without any evidence of liver disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Alcoholic Steatohepatitis and Alcoholic liver disease 2. Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH)
Key inclusion criteria (15 listed)
Key exclusion criteria (40 listed)
- Patients with cirrhosis due to alcohol related liver disease without AH with or without a prior episode of decompensation.
- Alcoholic liver disease with compensated never decompensated liver disease.
- Non-Alcoholic Fatty Liver (NAFL)
- Patients with compensated early NASH.
- Patients with NASH advance fibrosis or cirrhosis compensated or decompensated.
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
Molecular Subtypes for Targeted Therapies in Liver disease
Time frame: 5 years
* Generation of consistent non-invasive molecular footprints of disease severity and prognosis: plasma and peripheral blood cells from groups of patients with different disease prognosis will be analyzed by means of high throughput proteomics (Mass Spectrometry and aptamer mediated identification) and single cell RNA sequencing, respectively. Data will be integrated with liver RNA-sequencing to detect relevant liver fingerprints in plasma. * Mechanisms of ductular reaction and hepatocyte de-differentiation will be studied by micro-dissection and region-specific RNA-sequencing. * Mechanisms of hepatocyte dedifferentiation will be evaluated using methylation bead chip and chromatin immunoprecipitation coupled to DNA sequencing (ChIP-seq) of histone marks related with activation, enhancement, poisoning and repression of gene expression.
Determination of key drivers of the disease progression
Time frame: 5-10 years
* To describe and identified the histological patters in each phase of the disease (using imaging technics, including second harmonic generation imaging microscopy and electronic microscopy as well as classical IHC technics) * To quantified and compare the degree of hepatic steatosis and fibrosis assessed by non-invasive techniques such as FibroScan® (CAP controlled attenuation parameter) across different cohorts of patients and across the different stages of the disease within the same patient's phenotype. * To identify the main genetic. psychosocial, and environmental factors influencing the development of advanced liver fibrosis among patients with known or suspected excessive alcohol intake. Through DNA
repository capable of providing a framework fro the other outcomes
Time frame: 2-10 years
To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcoholic hepatitis, control disease and healthy controls
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 7 Nov 2023.
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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.
Jaideep Behari, MD, PhD principal investigator
Associate Professor
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 Liver Disease and Non-Alcoholic Fatty Liver Disease, 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 15 inclusion and 40 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 7 Nov 2023. 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?
Molecular Subtypes for Targeted Therapies in Liver disease (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.