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

NCT06761209 | Recruiting

• 2 other identifiers: PAP_RIPH2_2020/212020-A02908-31
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Auto-immune Hepatitis

Keywords

autoantibodies; auto-immune hepatitis; prognosis; afrocaribbean population

Outcome Measures

Primary Outcomes (1)

• histological rereading of seronegative AIH

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

  Baseline

Secondary Outcomes (2)

• assessment of the severity of the disease

  6 months, 12 months

• Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.

  At inclusion

Study Arms (1)

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

Other: blood sampling

Interventions

blood sampling OTHER

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.

acute or chronic Auto-Immune Hepatitis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (2)

Hospital of Saint-Antoine

Paris, France, 75012, France

NOT YET RECRUITING

CHU de Pointe-à Pitre

Pointe à Pitre, Guadeloupe, 97159, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Moana Lemoinne, doctor

  chu de pointe à pitre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie SOTER, Promotion Unit manager

CONTACT

+590 590 934677; valerie.soter@chu-guadeloupe.fr

Eunice NUBRET, Project manager

CONTACT

+590 0590934686; eunice.nubret@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 7, 2025
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)