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

Study acronym: EVAH
StatusCompleted
PhaseNot specified
Started2024-10-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
notable
Trial completed
Final enrollment: 200 participants (planned 120)
Primary completion confirmed: September 2026 (last estimated October 2026)
2025-11-24
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-01→2026-10-10
Completion date2028-01→2026-10-10
Start dateestimated 2026-01→confirmed 2024-10-10
Study sitesdetails revised at 3 of 3 sites
2025-09-05
minor
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v1
Primary completion date2027-01→2028-01
Completion date2027-01→2028-01
Start date2025-01→2026-01
Study sitescontacts updated at 1 of 3 sites
Collaborators+37 characters
URC-CIC Paris Descartes Necker Cochin
Study titlerevised
Study of Populations Atat Risk of Developing Chronic Hepatitis Linked to Chronic Enteric Virus Infection in Patients withWith Primary Immunodeficiency and Secondary Humoral Deficiency
2024-10-24
minor
Original filing
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.
Trial Details
NCT Number NCT06659588
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Humoral Primary Immunodeficiencies (PIDs), Secondary Form of Humoral Immunodeficiencies, Combined Immunodeficiency (CID), Severe Combined Immunodeficiency (SCID)
Enrollment 200 participants
Start Date 2024-10-10
Primary Completion 2026-09-03 (estimated)
Study Completion 2026-09-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-24