Risk of chronic hepatitis from persistent gut viruses in people with humoral and combined immunodeficiencies
Study of Populations at Risk of Developing Chronic Hepatitis Linked to Chronic Enteric Virus Infection in Patients With Primary Immunodeficiency and Secondary Humoral Deficiency
This project will test whether persistent enteric viruses cause long-term liver disease in people with primary or secondary humoral immunodeficiencies, combined immunodeficiencies, or SCID after cell therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06659588 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll four cohorts—primary humoral immunodeficiencies, secondary humoral immunodeficiencies after anti-CD20 or CAR‑T therapy, combined immunodeficiencies, and SCID patients post-allograft with humoral defects—to identify patients at risk of enteric virus‑associated hepatitis (EVAH). Investigators will collect clinical, biological, and genetic data and obtain additional blood, stool, and urine samples taken alongside routine care. Samples will be screened for enteric viruses using multiplex RT‑PCR and targeted PCR panels, and cases suspected of EVAH will be compared with control patients within each cohort. Immune-response and inflammatory markers will be analyzed to link viral persistence with hepatic pathology.
Who should consider this trial
Good fit: Ideal candidates are patients of any age followed at the CEREDIH centers in Paris who have primary humoral immunodeficiencies, secondary humoral deficiency after anti‑CD20 or CAR‑T therapy, combined immunodeficiency, or SCID more than two years after cell therapy.
Not a fit: Patients without humoral or combined immunodeficiency, those whose liver disease is clearly noninfectious (for example metabolic or classic autoimmune hepatitis), or patients unable to provide stool, urine, or plasma samples are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could enable earlier diagnosis of virus-linked liver disease and lead to targeted antiviral or immune‑modulating approaches to prevent or reduce hepatic complications.
How similar studies have performed: Previous work has applied stool and plasma viral PCRs in immunocompromised patients, but specifically linking chronic enteric viruses to nodular regenerative hyperplasia and EVAH is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 2 other locations
- Hôpital Saint-Louis — Paris, France (Recruiting)
- Hôpital Cochin — Paris, France (Recruiting)
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Victor Michel, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Victor Michel, MD
- Email: victor.michel@institutimagine.org
- Phone: 1 42 75 44 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.