Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de la Guadeloupe

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

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

Trial population

only acute or chronic AIH patients will be included in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood sampling

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: acute or chronic Auto-Immune Hepatitis patients1 intervention

Trial outcomes

Primary outcomes

1

histological rereading of seronegative AIH

Percentage comparisons will be made by a chi-2 test or a Fischer test.

Time frame
Baseline

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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