HEPATITIS C (HCV)MondeltaNCT07038863
Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France
A study testing Community screening for hepatitis B, C and delta in the Mongolian population living in France in people with HEPATITIS C (HCV) and Hepatitis B Virus (HBV), run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HEPATITIS C (HCV), Hepatitis B Virus (HBV), Hepatitis D
- What is being tested?
- Community screening for hepatitis B, C and delta in the Mongolian population living in France
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Sep 2025to 1 May 2028
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mongolian people
- Over 15 years of age
- Living in France
- Majors agree to participate or minors whose parental guardians agree to their child's participation in the study
Who cannot join
- People already followed for viral hepatitis, treated or not treated
- Persons deprived of their liberty by a judicial or administrative decision
- Adults subject to a legal protection measure (guardianship, curators)
- People participate in any interventional research except routine care research (old regulation) and category 2 research that does not interfere with the primary endpoint analysis
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites
Centre Hospitalier Annecy Genevois
Annecy
Frederic HELUWAERT, Dr, +33 4 50 63 63 07, fheluwaert@ch-annecygenevois.fr
Frederic HELUWAERT, Dr
Centre Expert Hépatites Virales Aquitaine, CHU de Bordeaux
Bordeaux
Juliette Foucher, Dr, +33 5 57 65 64 39, juliette.foucher@chu-bordeaux.fr
Juliette Foucher, Dr
CHU de Clermont Ferrand
Clermont-Ferrand
Armand ABERGEL, Pr, +33 4 73 75 05 23, aabergel@chu-clermontferrand.fr
Armand Abergel, Pr
Hôpital Henri Mondor - Assistante Publique Hopitaux de Paris (APHP)
Créteil
Vincent LEROY, Pr, +33 1 49 81 23 25, vincent.leroy2@aphp.fr
Vincent Leroy, Pr
CHU Grenoble Alpes
Grenoble
Marie Noelle Hilleret, Dr, +33 4 76 76 62 57, MNHilleret@chu-grenoble.fr
Marie Noelle Hilleret, Dr
CHRU Lille
Lille
Philippe MATHURIN, Pr, +33 3 20 44 55 97, p-mathurin@chru-lille.fr
Philippe MATHURIN, Pr
Service d'Hépatologie, Institut d'hépatologie de Lyon, Hôpital Croix-Rousse, Hospices Civils de Lyon
Lyon
Mahé RAFFIN, +33 4 26 73 27 38, mahe.raffin@chu-lyon.fr
François BAILLY, Dr
CHRU Rennes Pontchaillou
Rennes
Caroline Jezequel, Dr, +33299284298, caroline.jezequel@chu-rennes.fr
Caroline Jezequel, Dr
CHU de Rouen
Rouen
Ghassan Riachi, Dr, +33 2 32 88 66 33, Ghassan.Riachi@chu-rouen.fr
Ghassan Riachi, Dr
Hôpitaux Universitaires de Strasbourg
Strasbourg
Antonio SAVIANO, Dr, +33 3 69 55 16 04, antonio.saviano@chru-strasbourg.fr
Antonio SAVIANO, Dr
CHRU Bretonneau
Tours
Louis d'Alteroche, Dr, +33 2 47 47 59 16, L.DALTEROCHE@chu-tours.fr
Louis d'Alteroche, Dr
About this study
Official title: Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France
In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Viral hepatitis are essentially asymptomatic and therefore require systematic screening for diagnosis. Once a diagnosis of chronic viral infection has been established, specific therapies are available to reduce the morbidity and mortality of these patients. A study carried out in California in the Mongolian community found an HBV prevalence of 9.7% and positive HDV serology in 41% of these patients.
There is a large Mongolian community in France, estimated at between 5,000 and 6,000 patients. Although the majority of these patients are covered by French social security; however, access to care and screening for viral hepatitis often remain difficult and insufficient for migrant or vulnerable populations in France The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment.
- Conditions
- HEPATITIS C (HCV), Hepatitis B Virus (HBV), Hepatitis D, Hepatocellular Carcinoma (HCC), Liver Fibrosis
- Being tested
- Community screening for hepatitis B, C and delta in the Mongolian population living in France
- Keywords
- HBV, HCV, HDV, HCC
- Medical subject headings
- Hepatitis C, Hepatitis B, Hepatitis D, Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community screening for hepatitis B, C and delta in the Mongolian population living in FranceDiagnostic test
Screening will be organised in 11 centres in France, with 1 to 3 screening sessions per centre: patients will be informed of these screening sessions by the Mongolian Embassy in France, social networks and communities.
During this screening visit, Rapid Diagnostic Orientation Test (RDOT) will be carried out to screen for HBV and HCV. If the RDOT is negative for both viruses, an information on transmission and prevention of viral infection will be given.
If the RDOT is positive, confirmation of these tests by blood sampling will be organized and complementary biology (ASAT, ALAT, GGT, PAL, bilirubin total, bilirubin conjugated). If HBV RDOT positive, additional tubes will be collected for centralized analysis at the end of the study (VHD DNA, VHD genotyping, fibrotest and LCR1/2 test).
Once these confirmatory tests have been carried out, the patient will be referred to a hepatology consultation.
| Study group | Role | What they receive |
|---|---|---|
| Screening group | Experimental | This screening study focuses on Mongolian patients living in France. Screening will be organised in 11 centres in France, with 1 to 3 screening sessions per centre: patients will be informed of these screening sessions by the Mongolian Embassy in France, social networks and communities.
Screening will be carried out by Rapid Diagnostic Orientation Test (TRODS) for hepatitis B (HBV), hepatitis C (HCV) and hepatitis B (HCV). If the TRODs are positive, a confirmatory serology test will be carried out, followed by specialist hepatology treatment. Receives: Diagnostic Test: Community screening for hepatitis B, C and delta in the Mongolian population living in France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients positive for hepatitis B, hepatitis C and hepatitis D.
Number of patients with positive HBsAg (for HBV), positive serum HCV viral load (for HCV) and serum positive Delta viral load (for HDV) compared with all patients screened.
Measured: Visit 2 (Day 0 to Mounth 4)
Secondary outcomes (6)
Cascade of care for this screening strategy
Number of people tested positive for HBV, HCV or HDV who had a serological test, virological and elastometric evaluation, and hepatology consultation
Measured: 12 months after positive TROD screening
Information on preventing viral hepatitis
Number of Mongolian people attending the information and prevention session offered on each screening day
Measured: Baseline
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Evaluation of hepatic fibrosis using biological test by FibroTest
Measured: Day 1 or up to 4 months
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Evaluation of hepatic fibrosis using elastometry and biological test by FibroTest
Measured: Liver fibrosis will be assessed by elastometry and a FibroTest blood test, carried out according to the procedures of each centre, either during screening or at the specialist consultation.
Risk of hepatocellular carcinoma in patients positive for viral hepatitis
Evaluation of hepatocellular carcinoma (HCC) risk by biology (AFP)
Measured: Day 1 or up to 4 months
Risk of hepatocellular carcinoma in patients positive for viral hepatitis
Evaluation of hepatocellular carcinoma (HCC) risk by liver imaging (ultrasound or CT (computed tomography) /MRI (magnetic resonance imaging))
Measured: Day 1 or up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS C (HCV)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038863
- Sponsor's protocol ID
- 69HCL24_0469
- Other IDs
- 2025-A00086-43
- Acronym
- Mondelta
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France
- ClinicalTrials.gov ID
- NCT07038863
- Acronym / sponsor ID
- Mondelta / 69HCL24_0469
- Conditions
- HEPATITIS C (HCV), Hepatitis B Virus (HBV), Hepatitis D, Hepatocellular Carcinoma (HCC), Liver Fibrosis
- Keywords
- HBV, HCV, HDV, HCC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 26 Jun 2025 (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.
In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Viral hepatitis are essentially asymptomatic and therefore require systematic screening for diagnosis. Once a diagnosis of chronic viral infection has been established, specific therapies are available to reduce the morbidity and mortality of these patients. A study carried out in California in the Mongolian community found an HBV prevalence of 9.7% and positive HDV serology in 41% of these patients.
There is a large Mongolian community in France, estimated at between 5,000 and 6,000 patients. Although the majority of these patients are covered by French social security; however, access to care and screening for viral hepatitis often remain difficult and insufficient for migrant or vulnerable populations in France The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening group | Experimental | Diagnostic Test: Community screening for hepatitis B, C and delta in the Mongolian population living in FranceThis screening study focuses on Mongolian patients living in France. Screening will be organised in 11 centres in France, with 1 to 3 screening sessions per centre: patients will be informed of these screening sessions by the Mongolian Embassy in France, social networks and communities. Screening will be carried out by Rapid Diagnostic Orientation Test (TRODS) for hepatitis B (HBV), hepatitis C (HCV) and hepatitis B (HCV). If the TRODs are positive, a confirmatory serology test will be carried out, followed by specialist hepatology treatment. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mongolian people
- Over 15 years of age
- Living in France
- Majors agree to participate or minors whose parental guardians agree to their child's participation in the study
Key exclusion criteria (4 listed)
- People already followed for viral hepatitis, treated or not treated
- Persons deprived of their liberty by a judicial or administrative decision
- Adults subject to a legal protection measure (guardianship, curators)
- People participate in any interventional research except routine care research (old regulation) and category 2 research that does not interfere with the primary endpoint analysis
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 |
|---|---|---|
| Community screening for hepatitis B, C and delta in the Mongolian population living in FranceScreening will be organised in 11 centres in France, with 1 to 3 screening sessions per centre: patients will be informed of these screening sessions by the Mongolian Embassy in France, social networks and communities. During this screening visit, Rapid Diagnostic Orientation Test (RDOT) will be carried out to screen for HBV and HCV. If the RDOT is negative for both viruses, an information on transmission and prevention of viral infection will be given. If the RDOT is positive, confirmation of these tests by blood sampling will be organized and complementary biology (ASAT, ALAT, GGT, PAL, bilirubin total, bilirubin conjugated). If HBV RDOT positive, additional tubes will be collected for centralized analysis at the end of the study (VHD DNA, VHD genotyping, fibrotest and LCR1/2 test). Once these confirmatory tests have been carried out, the patient will be referred to a hepatology consultation. | Diagnostic test | Screening group |
Primary outcome
Number of patients positive for hepatitis B, hepatitis C and hepatitis D.
Time frame: Visit 2 (Day 0 to Mounth 4)
Number of patients with positive HBsAg (for HBV), positive serum HCV viral load (for HCV) and serum positive Delta viral load (for HDV) compared with all patients screened.
6 secondary outcomes
Cascade of care for this screening strategy
Time frame: 12 months after positive TROD screening
Information on preventing viral hepatitis
Time frame: Baseline
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Time frame: Day 1 or up to 4 months
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Time frame: Liver fibrosis will be assessed by elastometry and a FibroTest blood test, carried out according to the procedures of each centre, either during screening or at the specialist consultation.
Risk of hepatocellular carcinoma in patients positive for viral hepatitis
Time frame: Day 1 or up to 4 months
Risk of hepatocellular carcinoma in patients positive for viral hepatitis
Time frame: Day 1 or up to 4 months
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 26 Jun 2025.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community screening for hepatitis B, C and delta in the Mongolian population living in France in people with HEPATITIS C (HCV) and Hepatitis B Virus (HBV), run by Hospices Civils de Lyon at 11 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Contact François BAILLY, Dr (+33 4 26 73 27 33, francois.bailly@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients positive for hepatitis B, hepatitis C and hepatitis D. (time frame: Visit 2 (Day 0 to Mounth 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.