Liver Diseases, AlcoholicSIPHONNCT03308916
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
A study testing transient elastography, Enhanced liver fibrosis test and Indirect serum markers of liver fibrosis in people with Liver Diseases, Alcoholic and Fibrosis, run by Maja Thiele at 1 site in Denmark.
Trial summary
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Liver Diseases, Alcoholic, Fibrosis
- What is being tested?
- transient elastography, Enhanced liver fibrosis test and Indirect serum markers of liver fibrosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,500 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Oct 2017to 30 Oct 2035
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible for screening if the following inclusion criteria are fulfilled:
- Age 30-75 years (except the general population, which should be aged 40-75)
- Informed consent to study investigations
- Ability to read and write Danish AND (only at-risk patients)
- Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR
- Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;[38] OR
- Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol/L, HbA1c ≥48 mmol/mol, a random plasma glucose ≥11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol/L and/or 2 hour plasma glucose ≥11.1 mmol/L.
Who cannot join
- We will exclude patients from screening in case of:
- Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding.
- Known concurrent liver disease other than ALD and NAFLD.
- Cancer or other debilitating disease with an expected survival of less than 12 months.
- Inability to comply with the study protocol.
- In screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of:
Show all 10Show fewer
- Contraindications for a percutaneous liver biopsy
- Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal.
- Hepatic congestion or bile duct dilation evidenced by ultrasound.
- Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gastroenterology and Hepatology, Odense University Hospital
Odense, 5000
Maja Thiele, MD, PhD, 65412752 ext. 45, maja.thiele@rsyd.dk
Maja Thiele, MD PhD
About this study
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.
Read the detailed description
This protocol describes a prospective screening study at Odense University Hospital, Department of Gastroenterology and Hepatology. The investigators will use liver stiffness measurements with transient elastography to screen 3000 participants from at-risk populations and 3500 participants from the general population for advanced liver fibrosis. At-risk is defined as either (A) a prior or current alcohol overuse (≥21 units/week for men and ≥14 units/week for women) for more than 5 years, or (B) presence of the metabolic syndrome with or without concomitant type 2 diabetes mellitus.
The study goal is to evaluate the aptitude of transient elastography as a screening tool for advanced liver fibrosis, based on analyses of benefit, harm, detection rate, technical applicability and prognostic potential. Secondary aims are to compare novel serum markers of liver fibrosis as potential screening tools against transient elastography: The Enhanced Liver Fibrosis test, neoepitope markers of extracellular matrix turnover, cytokeratin-18 based markers and indirect indices of fibrosis from algorithms combining routine liver blood test. Screened participants with elevated liver stiffness (≥8.0 kiloPascal; estimated 400 participants with alcoholic liver disease, 400 participants with non-alcoholic fatty liver disease and 280 participants from the general population) will be investigated with 2-dimensional shear-wave elastography and abdominal ultrasonography and a liver biopsy to confirm or reject presence of advanced fibrosis.
All participants with a positive screening elastography will be invited for repeated liver stiffness measurements and serum fibrosis markers after a minimum of one year from inclusion.
Participants at risk of alcoholic and non-alcoholic liver disease, independent of liver stiffness measurement at inclusion, will be invited for repeated liver stiffness measurements and serum fibrosis markers after a minimum of one year from inclusion. At-risk participants with elevated liver stiffness measurements at a follow-up visit (>6.0 kiloPascal) will be offered a liver biopsy, however no earlier than two years after the index biopsy.
All participants will be followed for 10 years to assess liver-related outcomes and all-course mortality.
- Conditions
- Liver Diseases, Alcoholic, Fibrosis
- Being tested
- transient elastography, Enhanced liver fibrosis test, Indirect serum markers of liver fibrosis, Direct serum markers of liver fibrosis, LiverTRAIL
- Keywords
- elastography, screening, non-invasive markers, microbiome, gut-liver-axis, cost-benefit, fibroscan, aixplorer, ultrasound elastography, liver fibrosis, alcoholic liver disease, advanced fibrosis, enhanced liver fibrosis test, direct liver fibrosis markers, ELF, cytokeratin-18, neoepitopes, collagen, NAFLD, ALD
- Medical subject headings
- Liver Diseases, Alcoholic, Fibrosis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transient elastographyDiagnostic test
Also called FibroScan, TE
Ultrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis
Enhanced liver fibrosis testDiagnostic test
Also called ELF
Patented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1)
Indirect serum markers of liver fibrosisDiagnostic test
Also called Forns index, FIB-4, APRI, AST-ALT ratio
Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT
Direct serum markers of liver fibrosisDiagnostic test
Also called Neoepitopes, Collagen products, Extracellular matrix
Serum markers that reflect liver extracellular matrix turnover and -accumulation
LiverTRAILDiagnostic test
Software that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis.
Cytokeratin 18Diagnostic test
Also called CK18, M30, M65
Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65)
Omics markersDiagnostic test
Also called Multi-omics markers, Lipidomics, Microbiomics, Genomics
Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies
| Study group | Role | What they receive |
|---|---|---|
| Liver stiffness measurement | Experimental | Transient elastography in fasting state Receives: Diagnostic Test: transient elastography; Diagnostic Test: Enhanced liver fibrosis test; Diagnostic Test: Indirect serum markers of liver fibrosis; Diagnostic Test: Direct serum markers of liver fibrosis; Diagnostic Test: LiverTRAIL; Diagnostic Test: Cytokeratin 18; Diagnostic Test: Omics markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-verified advanced fibrosis
Number of patients with biopsy-verified, advanced fibrosis (Kleiner fibrosis score ≥F3) detected by screening
Measured: 5 years
Liver-related outcomes
Number of liver-related clinical outcomes during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts). Liver-related outcomes are defined as liver-related death, liver transplant, progression to liver-related complications (ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, jaundice, bleeding from esophagastric varices, hepatocellular carcinoma) or MELD-Na score >15
Measured: 10 years
Secondary outcomes (2)
Liver related outcomes
Number of liver-related clinical outcomes during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts). Liver-related outcomes are defined as liver-related death, liver transplant, progression to liver-related complications (ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, jaundice, bleeding from esophagastric varices, hepatocellular carcinoma) or MELD-Na score >15
Measured: 10 years
Mortality
Overall number of deaths during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start6 Oct 2017
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Oct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single intervention group selected for screening with a historical control group
- Masking
- None (open label)
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maja Thiele
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission, Novo Nordisk A/S, University of Southern Denmark, Esbjerg University Hospital of South-West Jutland, Odense Municipality Alcohol Rehabilitation Unit, Svendborg Municipality Alcohol Rehabilitation Unit, University of Copenhagen, University of Oslo, Nordic Bioscience A/S, VLV Bio, Peviva AB, Manatee APS, Siemens Healthcare A/S, Steno Diabetes Center Copenhagen, Biomedical Research Foundation, Academy of Athens, Heidelberg University
- Responsible party
- Sponsor-investigator, Maja Thiele, Odense University Hospital
- Investigators
- Maja Thiele, MD, PhD, Professor, Principal investigator, Department of Gastroenterology and Hepatology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308916
- Sponsor's protocol ID
- S-20170087
- Acronym
- SIPHON
- Status last verified
- Aug 2022
- First submitted
- 4 Feb 2016
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: OPEN - Odense Patient Exploratory data Network, managed by Odense University Hospital
Publications
Hansen CD, Hansen JK, Israelsen M, Andersen P, Pikkupeura LM, Lindvig KP, Stinson SE, Schnefeld HL, Tellerup J, Fogt M, Torp N, Kjaergaard M, Bech KT, Thorhauge KH, Johansen S, Spedtsberg I, Deluran E, Villesen IF, Detlefsen S, Hansen T, Krag A, Thiele M. Prevalence, severity and determinants of steatotic liver disease among individuals with metabolic and alcohol risk from the community. J Hepatol. 2025 Dec;83(6):1278-1291. doi: 10.1016/j.jhep.2025.06.020. Epub 2025 Jul 5.
PubMed 40618958Kjaergaard M, Lindvig KP, Thorhauge KH, Andersen P, Hansen JK, Kastrup N, Jensen JM, Hansen CD, Johansen S, Israelsen M, Torp N, Trelle MB, Shan S, Detlefsen S, Antonsen S, Andersen JE, Graupera I, Gines P, Thiele M, Krag A. Using the ELF test, FIB-4 and NAFLD fibrosis score to screen the population for liver disease. J Hepatol. 2023 Aug;79(2):277-286. doi: 10.1016/j.jhep.2023.04.002. Epub 2023 Apr 21.
PubMed 37088311
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
- ClinicalTrials.gov ID
- NCT03308916
- Acronym / sponsor ID
- SIPHON / S-20170087
- Conditions
- Liver Diseases, Alcoholic, Fibrosis
- Keywords
- elastography, screening, non-invasive markers, microbiome, gut-liver-axis, cost-benefit, fibroscan, aixplorer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Maja ThieleUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission, Novo Nordisk A/S, University of Southern Denmark, Esbjerg University Hospital of South-West Jutland, Odense Municipality Alcohol Rehabilitation Unit, Svendborg Municipality Alcohol Rehabilitation Unit, University of Copenhagen, University of Oslo, Nordic Bioscience A/S, VLV Bio, Peviva AB, Manatee APS, Siemens Healthcare A/S, Steno Diabetes Center Copenhagen, Biomedical Research Foundation, Academy of Athens, Heidelberg University
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Oct 2035 (estimated)
- First posted
- 13 Oct 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.
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.
Detailed description
This protocol describes a prospective screening study at Odense University Hospital, Department of Gastroenterology and Hepatology. The investigators will use liver stiffness measurements with transient elastography to screen 3000 participants from at-risk populations and 3500 participants from the general population for advanced liver fibrosis. At-risk is defined as either (A) a prior or current alcohol overuse (≥21 units/week for men and ≥14 units/week for women) for more than 5 years, or (B) presence of the metabolic syndrome with or without concomitant type 2 diabetes mellitus.
The study goal is to evaluate the aptitude of transient elastography as a screening tool for advanced liver fibrosis, based on analyses of benefit, harm, detection rate, technical applicability and prognostic potential. Secondary aims are to compare novel serum markers of liver fibrosis as potential screening tools against transient elastography: The Enhanced Liver Fibrosis test, neoepitope markers of extracellular matrix turnover, cytokeratin-18 based markers and indirect indices of fibrosis from algorithms combining routine liver blood test. Screened participants with elevated liver stiffness (≥8.0 kiloPascal; estimated 400 participants with alcoholic liver disease, 400 participants with non-alcoholic fatty liver disease and 280 participants from the general population) will be investigated with 2-dimensional shear-wave elastography and abdominal ultrasonography and a liver biopsy to confirm or reject presence of advanced fibrosis.
All participants with a positive screening elastography will be invited for repeated liver stiffness measurements and serum fibrosis markers after a minimum of one year from inclusion.
Participants at risk of alcoholic and non-alcoholic liver disease, independent of liver stiffness measurement at inclusion, will be invited for repeated liver stiffness measurements and serum fibrosis markers after a minimum of one year from inclusion. At-risk participants with elevated liver stiffness measurements at a follow-up visit (>6.0 kiloPascal) will be offered a liver biopsy, however no earlier than two years after the index biopsy.
All participants will be followed for 10 years to assess liver-related outcomes and all-course mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single intervention group selected for screening with a historical control group
| Arm | Type | Receives |
|---|---|---|
| Liver stiffness measurement | Experimental | Diagnostic Test: transient elastography, Diagnostic Test: Enhanced liver fibrosis test, Diagnostic Test: Indirect serum markers of liver fibrosis, Diagnostic Test: Direct serum markers of liver fibrosis, Diagnostic Test: LiverTRAIL, Diagnostic Test: Cytokeratin 18, Diagnostic Test: Omics markersTransient elastography in fasting state |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 30-75 years (except the general population, which should be aged 40-75)
- Informed consent to study investigations
- Ability to read and write Danish AND (only at-risk patients)
- Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR
- Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;[38] OR
Key exclusion criteria (10 listed)
- Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding.
- Known concurrent liver disease other than ALD and NAFLD.
- Cancer or other debilitating disease with an expected survival of less than 12 months.
- Inability to comply with the study protocol.
- In screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transient elastographyAlso: FibroScan, TEUltrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis | Diagnostic test | Liver stiffness measurement |
| Enhanced liver fibrosis testAlso: ELFPatented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1) | Diagnostic test | Liver stiffness measurement |
| Indirect serum markers of liver fibrosisAlso: Forns index, FIB-4, APRI, AST-ALT ratioDiagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT | Diagnostic test | Liver stiffness measurement |
| Direct serum markers of liver fibrosisAlso: Neoepitopes, Collagen products, Extracellular matrixSerum markers that reflect liver extracellular matrix turnover and -accumulation | Diagnostic test | Liver stiffness measurement |
| LiverTRAILSoftware that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis. | Diagnostic test | Liver stiffness measurement |
| Cytokeratin 18Also: CK18, M30, M65Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65) | Diagnostic test | Liver stiffness measurement |
| Omics markersAlso: Multi-omics markers, Lipidomics, Microbiomics, GenomicsMarkers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies | Diagnostic test | Liver stiffness measurement |
Primary outcome
Biopsy-verified advanced fibrosis
Time frame: 5 years
Number of patients with biopsy-verified, advanced fibrosis (Kleiner fibrosis score ≥F3) detected by screening
Liver-related outcomes
Time frame: 10 years
Number of liver-related clinical outcomes during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts). Liver-related outcomes are defined as liver-related death, liver transplant, progression to liver-related complications (ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, jaundice, bleeding from esophagastric varices, hepatocellular carcinoma) or MELD-Na score >15
2 secondary outcomes
Liver related outcomes
Time frame: 10 years
Mortality
Time frame: 10 years
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 1 Sep 2022.
- Derived from this study: PubMed 40618958Hansen CD, Hansen JK, Israelsen M, Andersen P, Pikkupeura LM, Lindvig KP, Stinson SE, Schnefeld HL, Tellerup J, Fogt M, Torp N, Kjaergaard M, Bech KT, Thorhauge KH, Johansen S, Spedtsberg I, Deluran E, Villesen IF, Detlefsen S, Hansen T, Krag A, Thiele M. Prevalence, severity and determinants of steatotic liver disease among individuals with metabolic and alcohol risk from the community. J Hepatol. 2025 Dec;83(6):1278-1291. doi: 10.1016/j.jhep.2025.06.020. Epub 2025 Jul 5.
- Derived from this study: PubMed 37088311Kjaergaard M, Lindvig KP, Thorhauge KH, Andersen P, Hansen JK, Kastrup N, Jensen JM, Hansen CD, Johansen S, Israelsen M, Torp N, Trelle MB, Shan S, Detlefsen S, Antonsen S, Andersen JE, Graupera I, Gines P, Thiele M, Krag A. Using the ELF test, FIB-4 and NAFLD fibrosis score to screen the population for liver disease. J Hepatol. 2023 Aug;79(2):277-286. doi: 10.1016/j.jhep.2023.04.002. Epub 2023 Apr 21.
- Individual participant dataSharing planned: Yes. OPEN - Odense Patient Exploratory data Network, managed by Odense University Hospital
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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.
Maja Thiele, MD, PhD, Professor principal investigator
Department of Gastroenterology and Hepatology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transient elastography, Enhanced liver fibrosis test and Indirect serum markers of liver fibrosis in people with Liver Diseases, Alcoholic and Fibrosis, run by Maja Thiele at 1 site in Denmark.
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 7 inclusion and 10 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 1 Sep 2022. 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 Denmark. 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 Maja Thiele, MD, PhD, Professor (+4524998068, maja.thiele@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy-verified advanced fibrosis (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT03308916, which also lists 2 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 1 Sep 2022.