An observational study in Auto-immune Hepatitis, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational
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.
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.
343 studies on the registry are indexed under Hepatitis; 51 are open to participants now.
This study's planned enrollment of 100 is below the median of 358 across 90 observational studies indexed under Hepatitis.
Browse Hepatitis studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
only acute or chronic AIH patients will be included in the study.
Inclusion Criteria:
Free, informed and written consent signed by the patient and the investigator
o exclusion criteria: - Patient under 18 years old
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: blood sampling
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.
histological rereading of seronegative AIH
Percentage comparisons will be made by a chi-2 test or a Fischer test.
Time frame: Baseline
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.
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.
Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.
Time frame: At inclusion
Plan to share: No
No publications or documents are linked to this record.
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Centre Hospitalier Universitaire de la Guadeloupe