Study of Populations At Risk of Developing Chronic Hepatitis Linked to Chronic Enteric Virus Infection in Patients with Primary Immunodeficiency and Secondary Humoral Deficiency

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying patients who are at risk of developing chronic hepatitis linked to certain viral infections, particularly in individuals with specific immune system deficiencies. The researchers want to understand how these conditions, especially in people with primary and secondary humoral immunodeficiencies, might lead to liver issues when they have chronic enteric virus infections. They will look at four groups of patients: those with primary humoral immune deficiencies, those with secondary immune deficiencies (after specific treatments), and those with combined immunodeficiencies, including severe combined immunodeficiency (SCID).

To participate in the trial, patients of any age must be receiving care at designated hospitals and meet specific criteria related to their immune conditions. Participants can expect to provide blood, stool, and urine samples for testing, which will help the researchers identify any enteric viruses and better understand the immune responses involved. The trial is not yet recruiting, but it aims to gather valuable information that could improve the understanding and treatment of these complex immune disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Information and non-opposition from the legal representatives of minor patients, the patients themselves and adult patients of the population of interest.
• Population of interest:
• Patients with no age limit followed in one of the skills centers of the Reference Center for Hereditary Immunodeficiencies (CEREDIH) within the APHP (Necker-Enfants Malades hospital, Saint-Louis Hospital and Cochin hospital) and presenting:
• • Humoral primary immunodeficiencies (PIDs) defined according to the IUIS (International Union of Immunological Societies) criteria
• • Secondary form of humoral immunodeficiencies (post anti-CD20 monoclonal antibody or post CAR-T cells therapy with alymphocytosis B and/or hypo IgA or IgM or IgG)
• • Combined immunodeficiency (CID) defined according to the IUES criteria
• • Severe combined immunodeficiency (SCID) beyond 2 years post cell therapy (allogeneic haematopoietic stem cell transplantation (aHSCT) or gene therapy)
• Exclusion Criteria:
• • Patients not belonging to one of the target populations
• • Opposition of legal representatives of minor patients, patients themselves and adult patients