Auto-immune HepatitisHAI-NEGNCT06761209
Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?
An observational study of Auto-immune Hepatitis, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in France.
Trial summary
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auto-immune Hepatitis
- What is being tested?
- blood sampling
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 2022to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: only acute or chronic AIH patients will be included in the study.
Who may be able to join
- - Any patient over 18 years old
- Patient followed at Hôpital Saint-Antoine or treated for HAI or in Guadeloupe within the framework of the CCRD Filfoie for an acute or chronic AIH under immunosuppressive treatment
- Patient affiliate or beneficiary of a social security scheme
- Free, informed and written consent signed by the patient and the investigator
- o exclusion criteria: - Patient under 18 years old
- Patient not able to give his/her consent
Show all 15Show fewer
- Viral hepatitis: viruses A to E, Epstein-Barr virus, cytomegalovirus and herpes simplex virus
- Isolated primary biliary cholangitis
- Isolated primary sclerosing cholangitis
- Drug-induced liver injury
- Wilson disease
- Alcoholic hepatitis
- Hemochromatosis
- Sickle cell disease and heart liver
- Non-alcoholic steato-hepatitis
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Hospital of Saint-Antoine
Paris, France, 75012
Sara Lemoinne, doctor, sara.lemoinne@aphp.fr
Sara LEMOINNE, Doctor
- Recruiting
CHU de Pointe-à Pitre
Pointe à Pitre, Guadeloupe, 97159
Moana GELU-SIMEON, medecine degree,, +590 0590891446, moana.simeon@chu-guadeloupe.fr
eunice.nubret@chu-guadeloupe.fr
About this study
Official title: Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.
Read the detailed description
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.
Patients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and from the Saint-Antoine hospital will be retrospectively analyzed, and new patients will be prospectively followed.
- Conditions
- Auto-immune Hepatitis
- Being tested
- blood sampling
- Keywords
- autoantibodies, auto-immune hepatitis, prognosis, afrocaribbean population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
For the study, a blood sample will be collected from the patient in order to do build up a serological library which will allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease.
| Study group | Role | What they receive |
|---|---|---|
| acute or chronic Auto-Immune Hepatitis patients | For the study, a blood sample will be collected from the patient in order to build up a serological library which allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological rereading of seronegative AIH
Percentage comparisons will be made by a chi-2 test or a Fischer test.
Measured: Baseline
Secondary outcomes (2)
assessment of the severity of the disease
- Number of corticosteroid HAI defined by the maintenance of corticosteroid therapy> 20mg / d beyond 6 months of treatment - Number of corticosteroid-resistant AIH. Percentage comparisons will be made by a chi-2 test or a Fischer test.
Measured: 6 months, 12 months
Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.
Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto-immune HepatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moana Lemoinne, doctor, Principal investigator, chu de pointe à pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761209
- Sponsor's protocol ID
- PAP_RIPH2_2020/21
- Other IDs
- 2020-A02908-31
- Acronym
- HAI-NEG
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
- ClinicalTrials.gov ID
- NCT06761209
- Acronym / sponsor ID
- HAI-NEG / PAP_RIPH2_2020/21
- Conditions
- Auto-immune Hepatitis
- Keywords
- autoantibodies, auto-immune hepatitis, prognosis, afrocaribbean population
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 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.
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.
Detailed description
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.
Patients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and from the Saint-Antoine hospital will be retrospectively analyzed, and new patients will be prospectively followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute or chronic Auto-Immune Hepatitis patients | – | Other: blood samplingFor the study, a blood sample will be collected from the patient in order to build up a serological library which allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- only acute or chronic AIH patients will be included in the study.
Key inclusion criteria (15 listed)
- - Any patient over 18 years old
- Patient followed at Hôpital Saint-Antoine or treated for HAI or in Guadeloupe within the framework of the CCRD Filfoie for an acute or chronic AIH under immunosuppressive treatment
- Patient affiliate or beneficiary of a social security scheme
- Free, informed and written consent signed by the patient and the investigator
- o exclusion criteria: - Patient under 18 years old
Key exclusion criteria (0 listed)
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 samplingFor the study, a blood sample will be collected from the patient in order to do build up a serological library which will allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease. | Other | acute or chronic Auto-Immune Hepatitis patients |
Primary outcome
histological rereading of seronegative AIH
Time frame: Baseline
Percentage comparisons will be made by a chi-2 test or a Fischer test.
2 secondary outcomes
assessment of the severity of the disease
Time frame: 6 months, 12 months
Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.
Time frame: At inclusion
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 7 Jan 2025.
- Individual participant dataSharing planned: No
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.
Moana Lemoinne, doctor principal investigator
chu de pointe à pitre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auto-immune Hepatitis, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 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 15 inclusion and 0 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Valérie SOTER, Promotion Unit manager (+590 590 934677, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological rereading of seronegative AIH (time frame: Baseline). 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 7 Jan 2025.