Liver CirrhosisVICISNCT03267615
VICIS - Vienna Cirrhosis Study
An observational study of Liver Cirrhosis and Portal Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Ascites
- How many people
- 10,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2017to 31 Dec 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with advanced chronic liver disease diagnosed and/or treated at the Medical University of Vienna will be screened for inclusion/exclusion criteria.
Who may be able to join
- Age >18 years and <100 years
- Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG>5mmHg or Histology F3/F4)
- Written informed consent
Who cannot join
- Withdrawal of written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Thomas Reiberger, M.D., +43140400 ext. 47440, thomas.reiberger@meduniwien.ac.at
Alexandra Weisgram, +43140400 ext. 47410, alexandra.weisgram@meduniwien.ac.at
About this study
Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank.
Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital.
This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.
Read the detailed description
Patients with advanced chronic liver disease (ACLD) as evident by HVPG>5mmHg or liver biopsy showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be included in the VICIS study. Most patients will be recruited on the day of HVPG measurement performed for screening of clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailed characterization of patients by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver (LSM) and spleen (SSM) stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound and optionally cross-sectional imaging.
In addition, patients will be asked to (optionally) participate in biobank sampling including serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients recruited in the VICIS study will be prospectively followed every 3 months (decompenated ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis Outpatient Clinic at the Vienna General Hospital. These assessments include a detailed assessment of risk factors (such as a structured interview of alcohol consumption), the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, recording of medications and other clinically-relevant information.
- Conditions
- Liver Cirrhosis, Portal Hypertension, Ascites, Variceal Hemorrhage, Hepatic Encephalopathy
- Keywords
- Liver Cirrhosis, Portal Hypertension
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Ascites, Hepatic Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-free survival
Time from inclusion to death or liver transplantation
Measured: 01/FEB/2017 - 31/DECEMBER/2027
Secondary outcomes (1)
Decompensation-free survival
Time from inclusion to decompensation, death or liver transplantation
Measured: 01/FEB/2017 - 31/DECEMBER/2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Feb 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Reiberger, Medical University of Vienna
- Investigators
- Thomas Reiberger, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267615
- Sponsor's protocol ID
- VICIS
- Acronym
- VICIS
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2017
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kramer G, Lie-Ungurean IA, Hofer BS, Hartl L, Jachs M, Balcar L, Semmler G, Sebesta C, Thone P, Hintersteininger M, Hofinger P, Marculescu R, Perkmann T, Schwabl P, Trauner M, Mandorfer M, Reiberger T, Simbrunner B. Circulating fibronectin levels are linked to liver function, matrix remodeling, and hemostatic complications in advanced chronic liver disease. Hepatol Int. 2026 Sep 25. doi: 10.1007/s12072-026-11140-1. Online ahead of print.
PubMed 42789231Simbrunner B, Sorribas M, Schaerer J, Felber M, Codinach J, Gomes Rodrigues S, Mandorfer M, Berzigotti A, Trauner M, Reiberger T, Hammer J, Wiest R. Intestinal barrier dysfunction assessed by confocal laser endomicroscopy correlates with cirrhosis severity and clinical outcome☆. JHEP Rep. 2026 Sep 18:102037. doi: 10.1016/j.jhepr.2026.102037. Online ahead of print.
PubMed 42759696Kramer G, Hildeman A, Tozzi C, Maghsood R, Kalatharan V, Koo HN, Jastrzebska K, Svangard N, Donoghue C, Simbrunner B, Hofer BS, Mandorfer M, Reiberger T, Oscarsson J, Ambery P. A machine learning approach to non-invasive prediction of hepatic decompensation in compensated advanced chronic liver disease: The CIRI model. J Hepatol. 2026 Jul 16:S0168-8278(26)02716-9. doi: 10.1016/j.jhep.2026.06.042. Online ahead of print.
PubMed 42462822Simbrunner B, Semmler G, Bofill Roig M, Meyer EL, Balcar L, Jachs M, Hartl L, Hofer BS, Kramer G, Thone P, Sebesta C, Dominik N, Marculescu R, Quehenberger P, Scheiner B, Schwabl P, Stattermayer AF, Trauner M, Reiberger T, Mandorfer M. Stage-Specific Drivers of Clinical Progression in Advanced Chronic Liver Disease. Clin Gastroenterol Hepatol. 2026 Jun 17:S1542-3565(26)00445-3. doi: 10.1016/j.cgh.2026.06.011. Online ahead of print.
PubMed 42309430Pfisterer N, Lie-Ungurean I, Maurer J, Bauer D, Hengstschlaeger H, Noe A, Balcar L, Scheiner B, Schwabl P, Marculescu R, Woran K, Mozayani B, Madl C, Trauner M, Mandorfer M, Reiberger T, Simbrunner B. The Link of Portal-Hypertensive Gastropathy to Anaemia, Systemic Inflammation and Disease Progression in Cirrhosis. Liver Int. 2026 Jun;46(6):e70700. doi: 10.1111/liv.70700.
PubMed 42174757Kramer G, Simbrunner B, Jachs M, Balcar L, Hofer BS, Dominik N, Hartl L, Schwarz M, Semmler G, Sebesta C, Thone P, Geisselbrecht S, Maasoumy B, Alvarez E, McCoy MS, Petrenko O, Reinis J, Schwabl P, Stattermayer AF, Trauner M, Mandorfer M, Reiberger T. Blood-based Vienna 3P/5P risk models accurately predict first hepatic decompensation in compensated advanced chronic liver disease. JHEP Rep. 2025 Oct 17;8(2):101642. doi: 10.1016/j.jhepr.2025.101642. eCollection 2026 Feb.
PubMed 41551411Jachs M, Carvalho T, Simbrunner B, Semmler G, Hartl L, Balcar L, Hofer BS, Thone P, Dominik N, Kramer G, Sebesta C, Schwarz M, Bauer D, Stattermayer AF, Pinter M, Trauner M, Reiberger T, Mandorfer M. Indocyanine Green Clearance Correlates With Biomarkers Reflecting Key Disease-Driving Mechanisms in Advanced Chronic Liver Disease and Predicts Acute-on-Chronic Liver Failure and Death. Aliment Pharmacol Ther. 2026 Mar;63(6):874-884. doi: 10.1111/apt.70447. Epub 2025 Nov 5.
PubMed 41194563Simbrunner B, Villesen IF, Semmler G, Balcar L, Kramer G, Almeida Calvao J, Hofer BS, Jachs M, Hartl L, Maurer J, Scheiner B, Zinober K, Marculescu R, Trauner M, Karsdal M, Reiberger T, Mandorfer M, Leeming DJ. Biomarkers of Extracellular Matrix Remodelling Are Linked to Severity and Outcome of Advanced Chronic Liver Disease. Aliment Pharmacol Ther. 2026 Mar;63(5):648-661. doi: 10.1111/apt.70407. Epub 2025 Oct 12.
PubMed 41077886Dominik N, Simbrunner B, Scheiner B, Schwarz M, Hartl L, Jachs M, Balcar L, Semmler G, Kramer G, Sebesta C, Trauner M, Pinter M, Mandorfer M, Reiberger T, Hofer BS. Smoking Aggravates Inflammation, Fibrogenesis, Angiogenesis and Cancer Risk in Patients With Cirrhosis. Liver Int. 2025 Oct;45(10):e70314. doi: 10.1111/liv.70314.
PubMed 40899194Hartl L, Hintersteininger M, Simbrunner B, Jachs M, Hofer BS, Bauer DJM, Dominik N, Schwarz M, Balcar L, Kramer G, Kerbert AJC, Coenraad MJ, Thevenot T, Moreau R, Trebicka J, Claria J, Marculescu R, Trauner M, Mandorfer M, Reiberger T. The Vasopressin Biomarker Copeptin Is Linked to Systemic Inflammation and Refines Prognostication in Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2026 Jan;24(1):131-140. doi: 10.1016/j.cgh.2025.04.030. Epub 2025 Jun 2.
PubMed 40467020Hofer BS, Simbrunner B, Konigshofer P, Brusilovskaya K, Petrenko O, Taru V, Sorz-Nechay T, Zinober K, Regnat K, Semmler G, Lackner C, Trauner M, Mandorfer M, Schwabl P, Reiberger T. Inflammation remains a dynamic component of portal hypertension in regressive alcohol-related cirrhosis. United European Gastroenterol J. 2025 Apr;13(3):317-329. doi: 10.1002/ueg2.12643. Epub 2024 Dec 21.
PubMed 39708052Simbrunner B, Hofer BS, Schwabl P, Zinober K, Petrenko O, Fuchs C, Semmler G, Marculescu R, Mandorfer M, Datz C, Trauner M, Reiberger T. FXR-FGF19 signaling in the gut-liver axis is dysregulated in patients with cirrhosis and correlates with impaired intestinal defence. Hepatol Int. 2024 Jun;18(3):929-942. doi: 10.1007/s12072-023-10636-4. Epub 2024 Feb 8.
PubMed 38332428Hartl L, Simbrunner B, Jachs M, Wolf P, Bauer DJM, Scheiner B, Balcar L, Semmler G, Schwarz M, Marculescu R, Dannenberg V, Trauner M, Mandorfer M, Reiberger T. Lower free triiodothyronine (fT3) levels in cirrhosis are linked to systemic inflammation, higher risk of acute-on-chronic liver failure, and mortality. JHEP Rep. 2023 Nov 1;6(1):100954. doi: 10.1016/j.jhepr.2023.100954. eCollection 2024 Jan.
PubMed 38125301Simbrunner B, Villesen IF, Scheiner B, Paternostro R, Schwabl P, Stattermayer AF, Marculescu R, Pinter M, Quehenberger P, Trauner M, Karsdal M, Lisman T, Reiberger T, Leeming DJ, Mandorfer M. Von Willebrand factor processing in patients with advanced chronic liver disease and its relation to portal hypertension and clinical outcome. Hepatol Int. 2023 Dec;17(6):1532-1544. doi: 10.1007/s12072-023-10577-y. Epub 2023 Aug 21.
PubMed 37605068Hartl L, Simbrunner B, Jachs M, Wolf P, Bauer DJM, Scheiner B, Balcar L, Semmler G, Schwarz M, Marculescu R, Trauner M, Mandorfer M, Reiberger T. An impaired pituitary-adrenal signalling axis in stable cirrhosis is linked to worse prognosis. JHEP Rep. 2023 May 11;5(8):100789. doi: 10.1016/j.jhepr.2023.100789. eCollection 2023 Aug.
PubMed 37484210
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VICIS - Vienna Cirrhosis Study
- ClinicalTrials.gov ID
- NCT03267615
- Acronym / sponsor ID
- VICIS / VICIS
- Conditions
- Liver Cirrhosis, Portal Hypertension, Ascites, Variceal Hemorrhage, Hepatic Encephalopathy
- Keywords
- Liver Cirrhosis, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Aug 2017 (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.
Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank.
Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital.
This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.
Detailed description
Patients with advanced chronic liver disease (ACLD) as evident by HVPG>5mmHg or liver biopsy showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be included in the VICIS study. Most patients will be recruited on the day of HVPG measurement performed for screening of clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailed characterization of patients by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver (LSM) and spleen (SSM) stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound and optionally cross-sectional imaging.
In addition, patients will be asked to (optionally) participate in biobank sampling including serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients recruited in the VICIS study will be prospectively followed every 3 months (decompenated ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis Outpatient Clinic at the Vienna General Hospital. These assessments include a detailed assessment of risk factors (such as a structured interview of alcohol consumption), the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, recording of medications and other clinically-relevant information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with advanced chronic liver disease diagnosed and/or treated at the Medical University of Vienna will be screened for inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- Age >18 years and <100 years
- Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG>5mmHg or Histology F3/F4)
- Written informed consent
Key exclusion criteria (1 listed)
- Withdrawal of written informed consent
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
Transplant-free survival
Time frame: 01/FEB/2017 - 31/DECEMBER/2027
Time from inclusion to death or liver transplantation
1 secondary outcome
Decompensation-free survival
Time frame: 01/FEB/2017 - 31/DECEMBER/2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 42789231Kramer G, Lie-Ungurean IA, Hofer BS, Hartl L, Jachs M, Balcar L, Semmler G, Sebesta C, Thone P, Hintersteininger M, Hofinger P, Marculescu R, Perkmann T, Schwabl P, Trauner M, Mandorfer M, Reiberger T, Simbrunner B. Circulating fibronectin levels are linked to liver function, matrix remodeling, and hemostatic complications in advanced chronic liver disease. Hepatol Int. 2026 Sep 25. doi: 10.1007/s12072-026-11140-1. Online ahead of print.
- Derived from this study: PubMed 42759696Simbrunner B, Sorribas M, Schaerer J, Felber M, Codinach J, Gomes Rodrigues S, Mandorfer M, Berzigotti A, Trauner M, Reiberger T, Hammer J, Wiest R. Intestinal barrier dysfunction assessed by confocal laser endomicroscopy correlates with cirrhosis severity and clinical outcome☆. JHEP Rep. 2026 Sep 18:102037. doi: 10.1016/j.jhepr.2026.102037. Online ahead of print.
- Derived from this study: PubMed 42462822Kramer G, Hildeman A, Tozzi C, Maghsood R, Kalatharan V, Koo HN, Jastrzebska K, Svangard N, Donoghue C, Simbrunner B, Hofer BS, Mandorfer M, Reiberger T, Oscarsson J, Ambery P. A machine learning approach to non-invasive prediction of hepatic decompensation in compensated advanced chronic liver disease: The CIRI model. J Hepatol. 2026 Jul 16:S0168-8278(26)02716-9. doi: 10.1016/j.jhep.2026.06.042. Online ahead of print.
- Derived from this study: PubMed 42309430Simbrunner B, Semmler G, Bofill Roig M, Meyer EL, Balcar L, Jachs M, Hartl L, Hofer BS, Kramer G, Thone P, Sebesta C, Dominik N, Marculescu R, Quehenberger P, Scheiner B, Schwabl P, Stattermayer AF, Trauner M, Reiberger T, Mandorfer M. Stage-Specific Drivers of Clinical Progression in Advanced Chronic Liver Disease. Clin Gastroenterol Hepatol. 2026 Jun 17:S1542-3565(26)00445-3. doi: 10.1016/j.cgh.2026.06.011. Online ahead of print.
- Derived from this study: PubMed 42174757Pfisterer N, Lie-Ungurean I, Maurer J, Bauer D, Hengstschlaeger H, Noe A, Balcar L, Scheiner B, Schwabl P, Marculescu R, Woran K, Mozayani B, Madl C, Trauner M, Mandorfer M, Reiberger T, Simbrunner B. The Link of Portal-Hypertensive Gastropathy to Anaemia, Systemic Inflammation and Disease Progression in Cirrhosis. Liver Int. 2026 Jun;46(6):e70700. doi: 10.1111/liv.70700.
- Derived from this study: PubMed 41551411Kramer G, Simbrunner B, Jachs M, Balcar L, Hofer BS, Dominik N, Hartl L, Schwarz M, Semmler G, Sebesta C, Thone P, Geisselbrecht S, Maasoumy B, Alvarez E, McCoy MS, Petrenko O, Reinis J, Schwabl P, Stattermayer AF, Trauner M, Mandorfer M, Reiberger T. Blood-based Vienna 3P/5P risk models accurately predict first hepatic decompensation in compensated advanced chronic liver disease. JHEP Rep. 2025 Oct 17;8(2):101642. doi: 10.1016/j.jhepr.2025.101642. eCollection 2026 Feb.
- Derived from this study: PubMed 41194563Jachs M, Carvalho T, Simbrunner B, Semmler G, Hartl L, Balcar L, Hofer BS, Thone P, Dominik N, Kramer G, Sebesta C, Schwarz M, Bauer D, Stattermayer AF, Pinter M, Trauner M, Reiberger T, Mandorfer M. Indocyanine Green Clearance Correlates With Biomarkers Reflecting Key Disease-Driving Mechanisms in Advanced Chronic Liver Disease and Predicts Acute-on-Chronic Liver Failure and Death. Aliment Pharmacol Ther. 2026 Mar;63(6):874-884. doi: 10.1111/apt.70447. Epub 2025 Nov 5.
- Derived from this study: PubMed 41077886Simbrunner B, Villesen IF, Semmler G, Balcar L, Kramer G, Almeida Calvao J, Hofer BS, Jachs M, Hartl L, Maurer J, Scheiner B, Zinober K, Marculescu R, Trauner M, Karsdal M, Reiberger T, Mandorfer M, Leeming DJ. Biomarkers of Extracellular Matrix Remodelling Are Linked to Severity and Outcome of Advanced Chronic Liver Disease. Aliment Pharmacol Ther. 2026 Mar;63(5):648-661. doi: 10.1111/apt.70407. Epub 2025 Oct 12.
- Derived from this study: PubMed 40899194Dominik N, Simbrunner B, Scheiner B, Schwarz M, Hartl L, Jachs M, Balcar L, Semmler G, Kramer G, Sebesta C, Trauner M, Pinter M, Mandorfer M, Reiberger T, Hofer BS. Smoking Aggravates Inflammation, Fibrogenesis, Angiogenesis and Cancer Risk in Patients With Cirrhosis. Liver Int. 2025 Oct;45(10):e70314. doi: 10.1111/liv.70314.
- Derived from this study: PubMed 40467020Hartl L, Hintersteininger M, Simbrunner B, Jachs M, Hofer BS, Bauer DJM, Dominik N, Schwarz M, Balcar L, Kramer G, Kerbert AJC, Coenraad MJ, Thevenot T, Moreau R, Trebicka J, Claria J, Marculescu R, Trauner M, Mandorfer M, Reiberger T. The Vasopressin Biomarker Copeptin Is Linked to Systemic Inflammation and Refines Prognostication in Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2026 Jan;24(1):131-140. doi: 10.1016/j.cgh.2025.04.030. Epub 2025 Jun 2.
- Derived from this study: PubMed 39708052Hofer BS, Simbrunner B, Konigshofer P, Brusilovskaya K, Petrenko O, Taru V, Sorz-Nechay T, Zinober K, Regnat K, Semmler G, Lackner C, Trauner M, Mandorfer M, Schwabl P, Reiberger T. Inflammation remains a dynamic component of portal hypertension in regressive alcohol-related cirrhosis. United European Gastroenterol J. 2025 Apr;13(3):317-329. doi: 10.1002/ueg2.12643. Epub 2024 Dec 21.
- Derived from this study: PubMed 38332428Simbrunner B, Hofer BS, Schwabl P, Zinober K, Petrenko O, Fuchs C, Semmler G, Marculescu R, Mandorfer M, Datz C, Trauner M, Reiberger T. FXR-FGF19 signaling in the gut-liver axis is dysregulated in patients with cirrhosis and correlates with impaired intestinal defence. Hepatol Int. 2024 Jun;18(3):929-942. doi: 10.1007/s12072-023-10636-4. Epub 2024 Feb 8.
- 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.
Thomas Reiberger, M.D. principal investigator
Medical University of Vienna
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 Liver Cirrhosis and Portal Hypertension, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Reiberger, M.D. (+43140400 ext. 65890, thomas.reiberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival (time frame: 01/FEB/2017 - 31/DECEMBER/2027). 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 NCT03267615, which also lists 28 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 25 Sep 2025.