Clinical trial NCT06761209: Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?
Official title: Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Auto-immune Hepatitis
Keywords: autoantibodies
auto-immune hepatitis
prognosis
afrocaribbean population
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: only acute or chronic AIH patients will be included in the study.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* - 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
* 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

Primary outcomes:
measure: histological rereading of seronegative AIH
timeFrame: Baseline
Secondary outcomes:
measure: assessment of the severity of the disease
timeFrame: 6 months, 12 months
measure: Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.
timeFrame: At inclusion
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: France
facility: CHU de Pointe-à Pitre
state: Guadeloupe
city: Paris
country: France
facility: Hospital of Saint-Antoine
Study officials:
affiliation: chu de pointe à pitre
name: Moana Lemoinne, doctor
role: PRINCIPAL_INVESTIGATOR
References: