Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis? (HAI-NEG)

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.

Study Overview

• Status: Recruiting
• Conditions: Auto-immune Hepatitis
• Intervention / Treatment: Other: blood sampling

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Valérie SOTER, Promotion Unit manager; Phone Number: +590 590 934677; Email: valerie.soter@chu-guadeloupe.fr
• Study Contact Backup: Name: Eunice NUBRET, Project manager; Phone Number: +590 0590934686; Email: eunice.nubret@chu-guadeloupe.fr

Study Locations

• France
  • Paris, France, 75012
    • Not yet recruiting
    • Hospital of Saint-Antoine
    • Contact: Sara Lemoinne, doctor; Email: sara.lemoinne@aphp.fr
    • Contact: Sara LEMOINNE, Doctor
  • Guadeloupe
    • Pointe-à-Pitre, Guadeloupe, France, 97159
      • Recruiting
      • CHU de Pointe-à Pitre
      • Contact: Moana GELU-SIMEON, medecine degree,; Phone Number: +590 0590891446; Email: moana.simeon@chu-guadeloupe.fr
      • Contact: Email: eunice.nubret@chu-guadeloupe.fr
      • Contact: Moana GELU-SIMEON, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
histological rereading of seronegative AIH	Percentage comparisons will be made by a chi-2 test or a Fischer test.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe
• Investigators: Principal Investigator: Moana Lemoinne, doctor, CHU de Pointe à Pitre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: prognosis; autoantibodies; auto-immune hepatitis; afrocaribbean population
• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis A; Hepatitis; Hepatitis, Autoimmune
• Other Study ID Numbers: PAP_RIPH2_2020/21; 2020-A02908-31 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No