Gene Discovery in CHB Patients to Identify Unknown Pathways That Lead to B and NK Cell Deregulation

NCT06853886 | Recruiting

• 1 other identifier: 87RI24_0023 (LiNKeB2)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

Natural Killer (NK) and B cell immune responses occur during the early stages of infection and are essential to eradicate it. Yet, chronic hepatitis B (CHB) infection occurs because the antiviral immune response is insufficient. In both NK and B cell studies we will explore the genetic alterations that occur during the varied chronic stages of the disease. We believe that our findings will allow us to understand the molecular signature of NK and B cells in the context of HBV infection.

Conditions

Chronic Hepatitis B Virus

Keywords

HBV; NK celles; TLR9; B cells

Outcome Measures

Primary Outcomes (1)

• RNA sequencing of B cells from CHB patients at different stages, description of their molecular signature

  At inclusion, day 0

Secondary Outcomes (1)

• RNA sequencing of NK cells from CHB patients at different stages, description of their molecular signature (protein expression measured by flow cytometry)

  At inclusion, day 0

Study Arms (2)

HBV patient

OTHER

a blood sample is done during a follow-up visit

Other: blood sample HBV patient

healthy volunteers

OTHER

a blood sample

Other: blood sample healthy volunteers

Interventions

blood sample HBV patient OTHER

During a boold sample at only one follow up visit: * 3 tubes EDTA 10 ml per patient * 1 tube "Paxgene" 1ml * 2 dry tube per patient

HBV patient

blood sample healthy volunteers OTHER

* 3 tubes EDTA ideally age and sex matched to CHB patient. * 1 tube "Paxgene" 1ml * 2 dry tube

healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥18 years old
• HBV infection or chronic HBV infection untreated or treated with a nucleoside or nucleotide analog
• Willing and able to provide written informed consent
• Affiliated with a social securityregimen
• Male or female, age between 18 and 80 years
• Willing and able to provide written informed consent

You may not qualify if:

• Co-infection with HCV, HIV or HDV (or HBV for healthy volunteer)
• Acute hepatitis in the year preceding recruitment
• Other liver diseases : alcohol, obesity (BMI\>30), diabetes, metabolic syndrome (dyslipidemia and/or known hypertension) - Underlying immunological or cancerous diseases
• Patient with a disability that prevents him/her from fully understanding the requirements of the trial - Patient under court protection, guardianship or curatorship
• Pregnant or breast-feeding women.
• A healthy volunteer whose vaccination status does not match that expected on the basis of serological results
• Positive HCV, HIV or HDV test in a patient
• Positive HBV, HCV, HIV or HDV test in a healthy volunteer

Sponsors & Collaborators

• University Hospital, Limoges: lead
• National Agency for Research on AIDS and Viral Hepatitis (ANRS): collaborator

Study Sites (3)

Centre d'Investigation Clinique

Limoges, 87042, France

RECRUITING

Limoges University Hospital

Limoges, 87042, France

RECRUITING

Hospice civils de Lyon

Lyon, 69004, France

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Véronqiue LOUSTAUD-RATTI, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique LOUSTAUD-RATTI, MD

CONTACT

+335 55 05 66 84; veronique.loustaud-ratti@unilim.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (3)