Fibrosis, LiverHEPGENNCT06366425
Screening for Chronic Liver Diseases in General Population
A study testing Blood sample then fibroscan in people with Fibrosis, Liver, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Fibrosis, Liver
- What is being tested?
- Blood sample then fibroscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2024to 1 Jan 2029
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Without known liver pathologies
- Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.
Who cannot join
- Fibroscan already performed in the last 12 months
- Failure to collect express oral consent
- Patient not affiliated with or not benefiting from a national health insurance scheme
- Patient protected by law
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Screening for Chronic Liver Diseases in the General Population. A Prospective Study
Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.
Read the detailed description
The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.
The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.
Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.
The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score >1.3) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.
- Conditions
- Fibrosis, Liver
- Being tested
- Blood sample then fibroscan
- Keywords
- Non-alcoholic fatty liver disease (NAFLD), Hepatocellular carcinoma (HCC), Chronic liver diseases, Linkage to care, Fibrosis research, Non-invasive diagnosis, FIB-4, Fibroscan
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample then fibroscanDiagnostic test
The patient takes a blood test if none less than 6 months old is available, including a complete blood count (CBC) and a hepatic check. The FIB-4 score will be calculated from this blood test.
If the result of the FIB-4 test is greater than 1.3 the person will be contacted by the SELHV (Service Expert de Lutte contre les Hépatites Virales) of the University Hospital of Montpellier in order to schedule, if she wishes, a second non-invasive screening examination of liver fibrosis by Fibroscan.
| Study group | Role | What they receive |
|---|---|---|
| Population with a chronic liver disease risk factor | Other | Patient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C. Receives: Diagnostic Test: Blood sample then fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the liver fibrosis screening acceptability (FIB-4)
percentage of patients who agreed to a FIB-4 blood test among all included patients offered screening.
Measured: During the inclusion assessment at day 1 (Visit 0)
Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)
percentage of patients who agreed to a FIB-4 blood test FIB-4 followed by Fibroscan (if FIB-4 score>1.3) among all included patients offered screening.
Measured: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
Secondary outcomes (6)
Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3
If FIB-4 Score>1.3 a pulse elastometry (Fibroscan®) will be performed. A fibrotest measurement of ≥10 KPa (Kilopascals) or a score ≥F3 will be considered as advanced hepatic fibrosis.
Measured: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
Prevalence of excessive consumption of alcohol
Excessive alcohol consumption will be evaluated by the AUDIT-C questionnaire (Alcohol Use Disorders Identification Test) with a score ranging from 0 (lower risk) to 12 (higher risk of misuse), a score of > or = 3 for women and > or = 4 for men indicates misuse.
Measured: During the inclusion assessment at day 1 (Visit 0)
Prevalence of a history or drug use
Rate of participants with a history or current use of drugs among included patients.
Answered by the patient face to face with the doctor.
Measured: During the inclusion assessment at day 1 (Visit 0)
The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)
The correlation will be evaluated by the rate of patients with risk factors for liver disease and advanced fibrosis, among all those who underwent Fibroscan.
A fibrotest measurement of ≥10 KPa (Kilopascals) or a score ≥F3 will be considered as advanced hepatic fibrosis
The presence of metabolic syndrom if at least 3 of the following risk factors are present : arterial hypertension (≥ 130/85 mmHg), hypertriglyceridemia (≥ 1.7 mmol/L), low HDL-cholesterol (Men< 1 mmol/L; women < 1.3 mmol/L) , android obesity (≥ 102 cm men; ≥ 88 cm women) and fasting hyperglycemia (> 100 mg/dL)
Presence of an alcohol use disorders : AUDIT-C questionnaire with a score of ≥ 3 for women and ≥ 4 for men indicates misuse.
Presence of diabetes in medical records.
Presence of hepatitis by using a serology blood test (Hepatitis C Virus : HCV RNA, surface antigen of the hepatitis B virus : HBsAg, anti HBsAg, anti HBCAg, HBV DNA, HBeAg, anti HBeAg, Delta virus in case of hepatitis B positivity).
Measured: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
prevalence of viral hepatitis
Diagnosis of hepatitis by using a rapid diagnostic orientation test (TROD) by collecting of a drop of blood from the fingertip which is placed on a plate with a reactive solution in order to establish the presence of antigens and/or with a serology blood test (( Hepatitis C Virus : HCV RNA, HCV+, surface antigen of the hepatitis B virus : HBsAg, anti HBsAg, anti HBCAg, HBV DNA, HBeAg, anti HBeAg, Delta virus in case of hepatitis B positivity).
Prevalence of viral hepatitis among all included patients.
Measured: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
Description of socio-demographic characteristics of participants
Description of the socio-demographic characteristics of people benefiting from an assessment of liver fibrosis by transient elastometry (Fibroscan®) as part of the study.
Socio-demographic characteristics will be collected by a patient questionnaire (age, education, profession, income, health insurance, marital status, housing, living conditions) realised face to face with the doctor.
Measured: During the inclusion assessment at day 1 (Visit 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start11 Sep 2024
- Primary completion21 Apr 2025
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fibrosis, LiverStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- On-call medical home (MMG) Clermont-Hérault, Medical office Montpeyroux, Medical office Clermont-Hérault, Medical office Aniane
- Responsible party
- Sponsor
- Investigators
- Magdalena MESZAROS, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366425
- Sponsor's protocol ID
- RECHMPL23_0272
- Acronym
- HEPGEN
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.
PubMed 18395077de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Gines P, Castera L, Lammert F, Graupera I, Serra-Burriel M, Allen AM, Wong VW, Hartmann P, Thiele M, Caballeria L, de Knegt RJ, Grgurevic I, Augustin S, Tsochatzis EA, Schattenberg JM, Guha IN, Martini A, Morillas RM, Garcia-Retortillo M, de Koning HJ, Fabrellas N, Pich J, Ma AT, Diaz MA, Roulot D, Newsome PN, Manns M, Kamath PS, Krag A; LiverScreen Consortium Investigators. Population screening for liver fibrosis: Toward early diagnosis and intervention for chronic liver diseases. Hepatology. 2022 Jan;75(1):219-228. doi: 10.1002/hep.32163. Epub 2021 Dec 10.
PubMed 34537988Dam-Larsen S, Franzmann M, Andersen IB, Christoffersen P, Jensen LB, Sorensen TI, Becker U, Bendtsen F. Long term prognosis of fatty liver: risk of chronic liver disease and death. Gut. 2004 May;53(5):750-5. doi: 10.1136/gut.2003.019984.
PubMed 15082596Teli MR, Day CP, Burt AD, Bennett MK, James OF. Determinants of progression to cirrhosis or fibrosis in pure alcoholic fatty liver. Lancet. 1995 Oct 14;346(8981):987-90. doi: 10.1016/s0140-6736(95)91685-7.
PubMed 7475591Marshall AD, Micallef M, Erratt A, Telenta J, Treloar C, Everingham H, Jones SC, Bath N, How-Chow D, Byrne J, Harvey P, Dunlop A, Jauncey M, Read P, Collie T, Dore GJ, Grebely J. Liver disease knowledge and acceptability of non-invasive liver fibrosis assessment among people who inject drugs in the drug and alcohol setting: The LiveRLife Study. Int J Drug Policy. 2015 Oct;26(10):984-91. doi: 10.1016/j.drugpo.2015.07.002. Epub 2015 Jul 16.
PubMed 26256938Mwamba-Kalambayi P, Etienne A, Chirpaz E, Gelu-Simeon M, Cuissard L, Deloumeaux J, et al. Étude comparative de la fréquence des hépatites B et C chez les personnes nouvellement diagnostiquées pour carcinome hépatocellulaire en France métropolitaine et dans les départements et régions d'outre-mer, 2015-2019. Bull Epidémiol Hebd. 2022;(3-4): 85-94.
Oberti F, Cailliez E, Hubert I et al. Dépistage de la fibrose hépatique en populations générale et de médecine générale (étude DEFIH). Gastroenterol Clin Biol 2006;30:A7.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Screening for Chronic Liver Diseases in the General Population. A Prospective Study
- ClinicalTrials.gov ID
- NCT06366425
- Acronym / sponsor ID
- HEPGEN / RECHMPL23_0272
- Conditions
- Fibrosis, Liver
- Keywords
- Non-alcoholic fatty liver disease (NAFLD), Hepatocellular carcinoma (HCC), Chronic liver diseases, Linkage to care, Fibrosis research, Non-invasive diagnosis, FIB-4, Fibroscan
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- On-call medical home (MMG) Clermont-Hérault, Medical office Montpeyroux, Medical office Clermont-Hérault, Medical office Aniane
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 15 Apr 2024 (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.
Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.
Detailed description
The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.
The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.
Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.
The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score >1.3) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population with a chronic liver disease risk factor | Other | Diagnostic Test: Blood sample then fibroscanPatient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 40 years
- Without known liver pathologies
- Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.
Key exclusion criteria (7 listed)
- Fibroscan already performed in the last 12 months
- Failure to collect express oral consent
- Patient not affiliated with or not benefiting from a national health insurance scheme
- Patient protected by law
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Blood sample then fibroscanThe patient takes a blood test if none less than 6 months old is available, including a complete blood count (CBC) and a hepatic check. The FIB-4 score will be calculated from this blood test. If the result of the FIB-4 test is greater than 1.3 the person will be contacted by the SELHV (Service Expert de Lutte contre les Hépatites Virales) of the University Hospital of Montpellier in order to schedule, if she wishes, a second non-invasive screening examination of liver fibrosis by Fibroscan. | Diagnostic test | Population with a chronic liver disease risk factor |
Primary outcome
Evaluation of the liver fibrosis screening acceptability (FIB-4)
Time frame: During the inclusion assessment at day 1 (Visit 0)
percentage of patients who agreed to a FIB-4 blood test among all included patients offered screening.
Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)
Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
percentage of patients who agreed to a FIB-4 blood test FIB-4 followed by Fibroscan (if FIB-4 score>1.3) among all included patients offered screening.
6 secondary outcomes
Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3
Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
Prevalence of excessive consumption of alcohol
Time frame: During the inclusion assessment at day 1 (Visit 0)
Prevalence of a history or drug use
Time frame: During the inclusion assessment at day 1 (Visit 0)
The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)
Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
prevalence of viral hepatitis
Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
Description of socio-demographic characteristics of participants
Time frame: During the inclusion assessment at day 1 (Visit 0)
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 22 Jun 2026.
- Background: PubMed 18395077Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.
- Background: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Background: PubMed 34537988Gines P, Castera L, Lammert F, Graupera I, Serra-Burriel M, Allen AM, Wong VW, Hartmann P, Thiele M, Caballeria L, de Knegt RJ, Grgurevic I, Augustin S, Tsochatzis EA, Schattenberg JM, Guha IN, Martini A, Morillas RM, Garcia-Retortillo M, de Koning HJ, Fabrellas N, Pich J, Ma AT, Diaz MA, Roulot D, Newsome PN, Manns M, Kamath PS, Krag A; LiverScreen Consortium Investigators. Population screening for liver fibrosis: Toward early diagnosis and intervention for chronic liver diseases. Hepatology. 2022 Jan;75(1):219-228. doi: 10.1002/hep.32163. Epub 2021 Dec 10.
- Background: PubMed 15082596Dam-Larsen S, Franzmann M, Andersen IB, Christoffersen P, Jensen LB, Sorensen TI, Becker U, Bendtsen F. Long term prognosis of fatty liver: risk of chronic liver disease and death. Gut. 2004 May;53(5):750-5. doi: 10.1136/gut.2003.019984.
- Background: PubMed 7475591Teli MR, Day CP, Burt AD, Bennett MK, James OF. Determinants of progression to cirrhosis or fibrosis in pure alcoholic fatty liver. Lancet. 1995 Oct 14;346(8981):987-90. doi: 10.1016/s0140-6736(95)91685-7.
- Background: PubMed 26256938Marshall AD, Micallef M, Erratt A, Telenta J, Treloar C, Everingham H, Jones SC, Bath N, How-Chow D, Byrne J, Harvey P, Dunlop A, Jauncey M, Read P, Collie T, Dore GJ, Grebely J. Liver disease knowledge and acceptability of non-invasive liver fibrosis assessment among people who inject drugs in the drug and alcohol setting: The LiveRLife Study. Int J Drug Policy. 2015 Oct;26(10):984-91. doi: 10.1016/j.drugpo.2015.07.002. Epub 2015 Jul 16.
- BackgroundMwamba-Kalambayi P, Etienne A, Chirpaz E, Gelu-Simeon M, Cuissard L, Deloumeaux J, et al. Étude comparative de la fréquence des hépatites B et C chez les personnes nouvellement diagnostiquées pour carcinome hépatocellulaire en France métropolitaine et dans les départements et régions d'outre-mer, 2015-2019. Bull Epidémiol Hebd. 2022;(3-4): 85-94.
- BackgroundOberti F, Cailliez E, Hubert I et al. Dépistage de la fibrose hépatique en populations générale et de médecine générale (étude DEFIH). Gastroenterol Clin Biol 2006;30:A7.
- Recommandations pour le diagnostic et le suivi non-invasif des maladies chronique du foie, Association Française pour l'étude du foie.Link provided by the sponsor.
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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.
Magdalena MESZAROS, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample then fibroscan in people with Fibrosis, Liver, run by University Hospital, Montpellier at 1 site in France.
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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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 France. 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?
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?
Evaluation of the liver fibrosis screening acceptability (FIB-4) (time frame: During the inclusion assessment at day 1 (Visit 0)). 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 NCT06366425, which also lists 8 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 22 Jun 2026.