Alcoholic Liver DiseaseNCT04070508
Early Detection of Alcoholic Liver Disease
An observational study of Alcoholic Liver Disease and Alcoholic Fibrosis of Liver, run by University of Pittsburgh.
Trial summary
This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Liver Disease, Alcoholic Fibrosis of Liver, Alcoholic Cirrhosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 3 Nov 2025
- How long will I take part?
- 1 Year
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy).
Who may be able to join
- Patients diagnosed with an alcohol use disorder (AUD) identification test (AUDIT) with a total score 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 or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, and/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.
- Patients with abnormal AST, ALT, GGT and/or bilirubin.
- 21 years of age or older.
- Signed informed consent.
Who cannot join
- Patients with a history of liver disease or decompensated advanced liver disease (i.e: jaundice episodes, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known hepatocellular carcinoma.
- Patients with severe extrahepatic disease or terminal illness.
- Patients who are pregnant or breast-feeding. However, pre-menopausal women capable of bearing children will be allowed to participate in the study provided they have a reliable method of birth control and have a negative pregnancy test prior to inclusion.
About this study
Official title: Early Detection of Advanced Liver Fibrosis in Patients With Excessive Alcohol Intake
This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis.
The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy).
Read more
Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors.
The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.
Read the detailed description
Background:
The Global Status Report on Alcohol and Health 2014 from the World Health Organization indicates that alcohol abuse accounts for 50% of cirrhosis worldwide. Therefore, alcoholic liver disease (ALD) is a main cause of advanced liver fibrosis globally. ALD encompasses a range of disorders including simple steatosis, alcoholic steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma. In addition, patients with underlying ALD and active drinking can develop an episode of acute-on-chronic liver injury called "alcoholic hepatitis", which portends a poor prognosis.
Most patients with ALD are identified during the late stages of the disease when liver decompensation occurs. In fact, a recent global epidemiologic study (GLADIS) showed that ALD is by far the liver disease that is detected at the latest stages (ratio of early/late referral negative 8-fold). These results strongly suggest that there is a dire need for the early detection of ALD patients, which currently is almost nonexistent.
A non-invasive method to screen for advanced fibrosis and cirrhosis is transient elastography (FibroScan®). This modality could potentially diagnose silent liver disease among heavy drinkers, allowing for earlier referral to a specialty liver clinic for further treatment.
Individual susceptibility to the development of advanced fibrosis among heavy drinkers is likely determined by a combination of environmental, genetic and epigenetic factors, yet the mechanisms are largely unknown.
Exposing the exact risk factors for the progression of subclinical liver disease to advanced fibrosis and cirrhosis among heavy alcohol users may assist with prognostication and help influence a patient's decision to abstain from alcohol.
The main goal of this study is to identify the prevalence of advanced liver fibrosis (F3 y F4) among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and refer those who already have evidence of advanced fibrosis (F3-4 stage) to a specialized ALD clinic for treatment. The secondary goal is, to identify the main psychosocial, environmental, genetic and epigenetic factors that influence the individual susceptibility to develop advanced ALD and design a risk algorithm taking into account the interaction between these factors.
Design: This is a prospective observational single center study.
Length of participation:
- Subjects without detection of advanced fibrosis: no follow-up requiered.
- Subjects with detection of advanced fibrosis: these patients will be referred to the specialist for surveillance. In this group of patients, the investigators will record the visits every six months as standard of care during the first year, and in each visit, a questionnaire will be performed.
End of the study: The duration of the project is expected to be two years.
Study development: Patients will be recruited within UPMC Presbyterian (Oakland) and UPMC McKeesport.
Study procedures:
- Screening procedure: Those patients willing to participate in the study will sign the informed consent before screening process. In this process, inclusion and exclusion criteria will be checked.
- Clinical and anthropometric data
- Questionnaire
- FibroScan®
- Blood, liver tissue, urine and saliva collection and testing
Statistics:
General features and characteristics of the analysis:
Descriptive statistics will be used to report baseline characteristics of our study population as well as the incidence and prevalence of variables of interest. Chi-square test will be used to compare frequency distributions between subgroups for categorical variables. Mann-Whitney U will be used to compare continuous variables when variables do not follow normal distributions. Univariate analyses, using Chi-square, Student's t-test and Mann-Whitney U test will be used to assess the association between potential factors and advanced fibrosis. Logistic regression models will be fitted to select the best subset of predictors for advanced fibrosis. Those factors showing a clinically and statistically significant association with the outcome in univariate analyses will be selected for the initial models. The final models will be fitted by using a step-wise forward method based on model Likelihood Ratios with the same significance level (p<0.05) for entering and dropping variables. The significance level will be set at p<0.05 for all the analyses. Statistical analyses will be performed using IBM SPSS Statistics.
Sample size:
The investigators calculated a sample size of 350 subjects. An interim analysis will be performed.
Direct access to data source:
Clinical data will be collected into a web-based and HIPAA-compatible database system. The information will be registered in the electronic record system, Research Electronic Data Capture (REDCap), which has been validated by the ERIS / EDC Support team to ensure HIPAA compliance. REDCap is also assessed by the Partners Information Security Risk Assessment Team to ensure compliance with all Partners HealthCare policies.
- Conditions
- Alcoholic Liver Disease, Alcoholic Fibrosis of Liver, Alcoholic Cirrhosis, Excessive Drinking, Alcohol Abuse, Alcohol Use Disorder
- Keywords
- early detection, alcoholic liver disease, alcohol
- Medical subject headings
- Liver Diseases, Alcoholic, Liver Cirrhosis, Alcoholic, Alcoholism, Alcohol-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced fibrosis and cirrhosis assessed by FibroScan
Prevalence of advanced liver fibrosis and cirrhosis among patients with excessive alcohol intake using FibroScan.
Cut-off value for advanced fibrosis (F3) >8 kPa.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Apr 2023 (estimated)
- Primary completion3 Oct 2023 (estimated)
- Study completion3 Nov 2025 (estimated)
Why it stopped: Staff in the lab have transitioned to a new institution so there are no personnel available to recruit or resume the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon Bataller, University of Pittsburgh
- Investigators
- RAMON BATALLER, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070508
- Sponsor's protocol ID
- STUDY19020346
- Status last verified
- Mar 2023
- First submitted
- 21 Aug 2019
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shah ND, Ventura-Cots M, Abraldes JG, Alboraie M, Alfadhli A, Argemi J, Badia-Aranda E, Arus-Soler E, Barritt AS 4th, Bessone F, Biryukova M, Carrilho FJ, Fernandez MC, Dorta Guiridi Z, El Kassas M, Eng-Kiong T, Queiroz Farias A, George J, Gui W, Thurairajah PH, Hsiang JC, Husic-Selimovic A, Isakov V, Karoney M, Kim W, Kluwe J, Kochhar R, Dhaka N, Costa PM, Nabeshima Pharm MA, Ono SK, Reis D, Rodil A, Domech CR, Saez-Royuela F, Scheurich C, Siow W, Sivac-Burina N, Dos Santos Traquino ES, Some F, Spreckic S, Tan S, Vorobioff J, Wandera A, Wu P, Yacoub M, Yang L, Yu Y, Zahiragic N, Zhang C, Cortez-Pinto H, Bataller R. Alcohol-Related Liver Disease Is Rarely Detected at Early Stages Compared With Liver Diseases of Other Etiologies Worldwide. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2320-2329.e12. doi: 10.1016/j.cgh.2019.01.026. Epub 2019 Jan 29.
PubMed 30708110Altamirano J, Bataller R. Alcoholic liver disease: pathogenesis and new targets for therapy. Nat Rev Gastroenterol Hepatol. 2011 Aug 9;8(9):491-501. doi: 10.1038/nrgastro.2011.134.
PubMed 21826088Raynard B, Balian A, Fallik D, Capron F, Bedossa P, Chaput JC, Naveau S. Risk factors of fibrosis in alcohol-induced liver disease. Hepatology. 2002 Mar;35(3):635-8. doi: 10.1053/jhep.2002.31782.
PubMed 11870378Lackner C, Spindelboeck W, Haybaeck J, Douschan P, Rainer F, Terracciano L, Haas J, Berghold A, Bataller R, Stauber RE. Histological parameters and alcohol abstinence determine long-term prognosis in patients with alcoholic liver disease. J Hepatol. 2017 Mar;66(3):610-618. doi: 10.1016/j.jhep.2016.11.011. Epub 2016 Nov 25.
PubMed 27894795Muntaner L, Altamirano JT, Augustin S, Gonzalez A, Esteban R, Guardia J, Genesca J. High doses of beta-blockers and alcohol abstinence improve long-term rebleeding and mortality in cirrhotic patients after an acute variceal bleeding. Liver Int. 2010 Sep;30(8):1123-30. doi: 10.1111/j.1478-3231.2010.02287.x. Epub 2010 Jun 1.
PubMed 20536715Mueller S, Seitz HK, Rausch V. Non-invasive diagnosis of alcoholic liver disease. World J Gastroenterol. 2014 Oct 28;20(40):14626-41. doi: 10.3748/wjg.v20.i40.14626.
PubMed 25356026Buch S, Stickel F, Trepo E, Way M, Herrmann A, Nischalke HD, Brosch M, Rosendahl J, Berg T, Ridinger M, Rietschel M, McQuillin A, Frank J, Kiefer F, Schreiber S, Lieb W, Soyka M, Semmo N, Aigner E, Datz C, Schmelz R, Bruckner S, Zeissig S, Stephan AM, Wodarz N, Deviere J, Clumeck N, Sarrazin C, Lammert F, Gustot T, Deltenre P, Volzke H, Lerch MM, Mayerle J, Eyer F, Schafmayer C, Cichon S, Nothen MM, Nothnagel M, Ellinghaus D, Huse K, Franke A, Zopf S, Hellerbrand C, Moreno C, Franchimont D, Morgan MY, Hampe J. A genome-wide association study confirms PNPLA3 and identifies TM6SF2 and MBOAT7 as risk loci for alcohol-related cirrhosis. Nat Genet. 2015 Dec;47(12):1443-8. doi: 10.1038/ng.3417. Epub 2015 Oct 19.
PubMed 26482880Bataller R, Gao B. Liver fibrosis in alcoholic liver disease. Semin Liver Dis. 2015 May;35(2):146-56. doi: 10.1055/s-0035-1550054. Epub 2015 May 14.
PubMed 25974900Moran-Salvador E, Mann J. Epigenetics and Liver Fibrosis. Cell Mol Gastroenterol Hepatol. 2017 Apr 26;4(1):125-134. doi: 10.1016/j.jcmgh.2017.04.007. eCollection 2017 Jul.
PubMed 28593184Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG Clinical Guideline: Alcoholic Liver Disease. Am J Gastroenterol. 2018 Feb;113(2):175-194. doi: 10.1038/ajg.2017.469. Epub 2018 Jan 16.
PubMed 29336434
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Advanced Liver Fibrosis in Patients With Excessive Alcohol Intake
- ClinicalTrials.gov ID
- NCT04070508
- Acronym / sponsor ID
- STUDY19020346
- Conditions
- Alcoholic Liver Disease, Alcoholic Fibrosis of Liver, Alcoholic Cirrhosis, Excessive Drinking, Alcohol Abuse, Alcohol Use Disorder
- Keywords
- early detection, alcoholic liver disease, alcohol
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Staff in the lab have transitioned to a new institution so there are no personnel available to recruit or resume the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 3 Oct 2023 (estimated)
- Study completion
- 3 Nov 2025 (estimated)
- First posted
- 28 Aug 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.
This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis.
The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy).
Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors.
The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.
Detailed description
Background:
The Global Status Report on Alcohol and Health 2014 from the World Health Organization indicates that alcohol abuse accounts for 50% of cirrhosis worldwide. Therefore, alcoholic liver disease (ALD) is a main cause of advanced liver fibrosis globally. ALD encompasses a range of disorders including simple steatosis, alcoholic steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma. In addition, patients with underlying ALD and active drinking can develop an episode of acute-on-chronic liver injury called "alcoholic hepatitis", which portends a poor prognosis.
Most patients with ALD are identified during the late stages of the disease when liver decompensation occurs. In fact, a recent global epidemiologic study (GLADIS) showed that ALD is by far the liver disease that is detected at the latest stages (ratio of early/late referral negative 8-fold). These results strongly suggest that there is a dire need for the early detection of ALD patients, which currently is almost nonexistent.
A non-invasive method to screen for advanced fibrosis and cirrhosis is transient elastography (FibroScan®). This modality could potentially diagnose silent liver disease among heavy drinkers, allowing for earlier referral to a specialty liver clinic for further treatment.
Individual susceptibility to the development of advanced fibrosis among heavy drinkers is likely determined by a combination of environmental, genetic and epigenetic factors, yet the mechanisms are largely unknown.
Exposing the exact risk factors for the progression of subclinical liver disease to advanced fibrosis and cirrhosis among heavy alcohol users may assist with prognostication and help influence a patient's decision to abstain from alcohol.
The main goal of this study is to identify the prevalence of advanced liver fibrosis (F3 y F4) among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and refer those who already have evidence of advanced fibrosis (F3-4 stage) to a specialized ALD clinic for treatment. The secondary goal is, to identify the main psychosocial, environmental, genetic and epigenetic factors that influence the individual susceptibility to develop advanced ALD and design a risk algorithm taking into account the interaction between these factors.
Design: This is a prospective observational single center study.
Length of participation:
- Subjects without detection of advanced fibrosis: no follow-up requiered.
- Subjects with detection of advanced fibrosis: these patients will be referred to the specialist for surveillance. In this group of patients, the investigators will record the visits every six months as standard of care during the first year, and in each visit, a questionnaire will be performed.
End of the study: The duration of the project is expected to be two years.
Study development: Patients will be recruited within UPMC Presbyterian (Oakland) and UPMC McKeesport.
Study procedures:
- Screening procedure: Those patients willing to participate in the study will sign the informed consent before screening process. In this process, inclusion and exclusion criteria will be checked.
- Clinical and anthropometric data
- Questionnaire
- FibroScan®
- Blood, liver tissue, urine and saliva collection and testing
Statistics:
General features and characteristics of the analysis:
Descriptive statistics will be used to report baseline characteristics of our study population as well as the incidence and prevalence of variables of interest. Chi-square test will be used to compare frequency distributions between subgroups for categorical variables. Mann-Whitney U will be used to compare continuous variables when variables do not follow normal distributions. Univariate analyses, using Chi-square, Student's t-test and Mann-Whitney U test will be used to assess the association between potential factors and advanced fibrosis. Logistic regression models will be fitted to select the best subset of predictors for advanced fibrosis. Those factors showing a clinically and statistically significant association with the outcome in univariate analyses will be selected for the initial models. The final models will be fitted by using a step-wise forward method based on model Likelihood Ratios with the same significance level (p<0.05) for entering and dropping variables. The significance level will be set at p<0.05 for all the analyses. Statistical analyses will be performed using IBM SPSS Statistics.
Sample size:
The investigators calculated a sample size of 350 subjects. An interim analysis will be performed.
Direct access to data source:
Clinical data will be collected into a web-based and HIPAA-compatible database system. The information will be registered in the electronic record system, Research Electronic Data Capture (REDCap), which has been validated by the ERIS / EDC Support team to ensure HIPAA compliance. REDCap is also assessed by the Partners Information Security Risk Assessment Team to ensure compliance with all Partners HealthCare policies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy).
Key inclusion criteria (5 listed)
- Patients diagnosed with an alcohol use disorder (AUD) identification test (AUDIT) with a total score 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 or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, and/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.
- Patients with abnormal AST, ALT, GGT and/or bilirubin.
- 21 years of age or older.
- Signed informed consent.
Key exclusion criteria (3 listed)
- Patients with a history of liver disease or decompensated advanced liver disease (i.e: jaundice episodes, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known hepatocellular carcinoma.
- Patients with severe extrahepatic disease or terminal illness.
- Patients who are pregnant or breast-feeding. However, pre-menopausal women capable of bearing children will be allowed to participate in the study provided they have a reliable method of birth control and have a negative pregnancy test prior to inclusion.
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
Advanced fibrosis and cirrhosis assessed by FibroScan
Time frame: baseline
Prevalence of advanced liver fibrosis and cirrhosis among patients with excessive alcohol intake using FibroScan. Cut-off value for advanced fibrosis (F3) >8 kPa.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Background: PubMed 30708110Shah ND, Ventura-Cots M, Abraldes JG, Alboraie M, Alfadhli A, Argemi J, Badia-Aranda E, Arus-Soler E, Barritt AS 4th, Bessone F, Biryukova M, Carrilho FJ, Fernandez MC, Dorta Guiridi Z, El Kassas M, Eng-Kiong T, Queiroz Farias A, George J, Gui W, Thurairajah PH, Hsiang JC, Husic-Selimovic A, Isakov V, Karoney M, Kim W, Kluwe J, Kochhar R, Dhaka N, Costa PM, Nabeshima Pharm MA, Ono SK, Reis D, Rodil A, Domech CR, Saez-Royuela F, Scheurich C, Siow W, Sivac-Burina N, Dos Santos Traquino ES, Some F, Spreckic S, Tan S, Vorobioff J, Wandera A, Wu P, Yacoub M, Yang L, Yu Y, Zahiragic N, Zhang C, Cortez-Pinto H, Bataller R. Alcohol-Related Liver Disease Is Rarely Detected at Early Stages Compared With Liver Diseases of Other Etiologies Worldwide. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2320-2329.e12. doi: 10.1016/j.cgh.2019.01.026. Epub 2019 Jan 29.
- Background: PubMed 21826088Altamirano J, Bataller R. Alcoholic liver disease: pathogenesis and new targets for therapy. Nat Rev Gastroenterol Hepatol. 2011 Aug 9;8(9):491-501. doi: 10.1038/nrgastro.2011.134.
- Background: PubMed 11870378Raynard B, Balian A, Fallik D, Capron F, Bedossa P, Chaput JC, Naveau S. Risk factors of fibrosis in alcohol-induced liver disease. Hepatology. 2002 Mar;35(3):635-8. doi: 10.1053/jhep.2002.31782.
- Background: PubMed 27894795Lackner C, Spindelboeck W, Haybaeck J, Douschan P, Rainer F, Terracciano L, Haas J, Berghold A, Bataller R, Stauber RE. Histological parameters and alcohol abstinence determine long-term prognosis in patients with alcoholic liver disease. J Hepatol. 2017 Mar;66(3):610-618. doi: 10.1016/j.jhep.2016.11.011. Epub 2016 Nov 25.
- Background: PubMed 20536715Muntaner L, Altamirano JT, Augustin S, Gonzalez A, Esteban R, Guardia J, Genesca J. High doses of beta-blockers and alcohol abstinence improve long-term rebleeding and mortality in cirrhotic patients after an acute variceal bleeding. Liver Int. 2010 Sep;30(8):1123-30. doi: 10.1111/j.1478-3231.2010.02287.x. Epub 2010 Jun 1.
- Background: PubMed 25356026Mueller S, Seitz HK, Rausch V. Non-invasive diagnosis of alcoholic liver disease. World J Gastroenterol. 2014 Oct 28;20(40):14626-41. doi: 10.3748/wjg.v20.i40.14626.
- Background: PubMed 26482880Buch S, Stickel F, Trepo E, Way M, Herrmann A, Nischalke HD, Brosch M, Rosendahl J, Berg T, Ridinger M, Rietschel M, McQuillin A, Frank J, Kiefer F, Schreiber S, Lieb W, Soyka M, Semmo N, Aigner E, Datz C, Schmelz R, Bruckner S, Zeissig S, Stephan AM, Wodarz N, Deviere J, Clumeck N, Sarrazin C, Lammert F, Gustot T, Deltenre P, Volzke H, Lerch MM, Mayerle J, Eyer F, Schafmayer C, Cichon S, Nothen MM, Nothnagel M, Ellinghaus D, Huse K, Franke A, Zopf S, Hellerbrand C, Moreno C, Franchimont D, Morgan MY, Hampe J. A genome-wide association study confirms PNPLA3 and identifies TM6SF2 and MBOAT7 as risk loci for alcohol-related cirrhosis. Nat Genet. 2015 Dec;47(12):1443-8. doi: 10.1038/ng.3417. Epub 2015 Oct 19.
- Background: PubMed 25974900Bataller R, Gao B. Liver fibrosis in alcoholic liver disease. Semin Liver Dis. 2015 May;35(2):146-56. doi: 10.1055/s-0035-1550054. Epub 2015 May 14.
- Background: PubMed 28593184Moran-Salvador E, Mann J. Epigenetics and Liver Fibrosis. Cell Mol Gastroenterol Hepatol. 2017 Apr 26;4(1):125-134. doi: 10.1016/j.jcmgh.2017.04.007. eCollection 2017 Jul.
- Background: PubMed 29336434Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG Clinical Guideline: Alcoholic Liver Disease. Am J Gastroenterol. 2018 Feb;113(2):175-194. doi: 10.1038/ajg.2017.469. Epub 2018 Jan 16.
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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, PhD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease and Alcoholic Fibrosis of Liver, run by University of Pittsburgh.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Advanced fibrosis and cirrhosis assessed by FibroScan (time frame: baseline). 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 NCT04070508, which also lists 10 linked publications.
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 17 Mar 2023.