Actively Recruiting

All Genders
NCT06659588

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-01

120

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

Dysimmune and specially hepatic immuno-pathological processes are frequent in patients with PIDs (primary immune deficiencies), particularly but not exclusively in patients with humoral defects. In the latter, nodular regenerative hyperplasia is a frequent complication. It is often associated with mislabeled chronic enteropathy. The investigators hypothesized that chronic viral infection with an enteric virus and the immune response that it implies might explain these processes. To identify populations at risk of EVAH (enteric virus-associated hepatitis), four cohorts of patients will be studied: * Primary humoral immune deficiencies * Secondary humoral immune deficiencies (following anti-CD20 monoclonal antibodies, CAR-T cells) * Combined immunodeficiencies * Severe combined immunodeficiency syndrome (SCID) after allograft with humoral defect The investigators will collect clinical, biological and genetic information and features related to immunological responses and inflammatory damage for these patients. The investigators will include EVAH suspected patients and control patients in each cohort. The investigators will take additional blood, stool and urine samples during the same time as the samples taken for the care. The investigators will carry out tests for enteric viruses screening on stool, urine and plasma. The investigators will perform the viral screening on organ biopsies taken as part of the care. A subgroup of representative patients (EVAH+ and EVAH-) will benefit from ancillary studies to characterize the leukocyte populations in the circulating blood and the immune response for these processes. In EVAH patients, the investigators will study specific anti-viral cellular response.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Information and non-opposition from legal representatives of minors or adult patients
  • Followed at a CEREDIH Reference Center hospital (Necker-Enfants Malades, Saint-Louis, or Cochin)
  • Diagnosis of humoral primary immunodeficiencies (PIDs) by IUIS criteria
  • Secondary humoral immunodeficiencies after anti-CD20 antibody or CAR-T cell therapy with B-cell alymphocytosis and/or low IgA, IgM, or IgG
  • Combined immunodeficiency (CID) by IUIS criteria
  • Severe combined immunodeficiency (SCID) more than 2 years after allogeneic stem cell transplant or gene therapy
Not Eligible

You will not qualify if you...

  • Patients not in the specified target populations
  • Opposition from legal representatives of minors or adult patients to participate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Hôpital Saint-Louis

Paris, France, 75010

Actively Recruiting

2

Hôpital Cochin

Paris, France, 75014

Actively Recruiting

3

Hôpital Necker-Enfants Malades

Paris, France, 75015

Actively Recruiting

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Research Team

V

Victor Michel, MD

CONTACT

H

Hélène Morel

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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