Finding gene changes in chronic hepatitis B that cause B cell and NK cell dysfunction
Gene Discovery in CHB Patients to Identify Unknown Pathways That Lead to B and NK Cell Deregulation
NA · University Hospital, Limoges · NCT06853886
This project will test whether specific gene changes in people with chronic hepatitis B explain why their B cells and natural killer (NK) cells stop working properly.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges (other) |
| Locations | 3 sites (Limoges and 2 other locations) |
| Trial ID | NCT06853886 on ClinicalTrials.gov |
What this trial studies
Researchers will collect blood samples from adults with chronic hepatitis B and from healthy volunteers and isolate B cells and NK cells for molecular study. They will profile gene expression and related signaling pathways implicated by prior work, including TLR9, CREB phosphorylation, and mTOR-related changes linked to the viral surface antigen HBsAg. Samples will include patients across different chronic stages and treatment statuses to compare genetic signatures associated with dysfunction. The goal is to define the molecular changes that underlie impaired B and NK cell responses in chronic HBV infection.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic hepatitis B (treated or untreated with nucleoside/nucleotide analogues) who can give informed consent and are affiliated with the French social security system are eligible.
Not a fit: People with co-infections (HCV, HIV, HDV), recent acute hepatitis, other significant liver or metabolic diseases, major immunological or cancerous conditions, pregnancy or breastfeeding, or those unable to consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could identify molecular targets to restore immune function and guide new treatment approaches for people with chronic hepatitis B.
How similar studies have performed: Previous ANRS-funded work and other studies have shown B and NK cell dysfunction linked to HBsAg effects on TLR9, CREB, and mTOR pathways, but a comprehensive genetic signature across patient stages remains uncharacterized.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Healthy volunteer must meet all of the following inclusion criteria to be eligible for participation in this study: * Male or female, age between 18 and 80 years * Willing and able to provide written informed consent Exclusion Criteria: * 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. Secondary exclusion criteria: * A healthy volunteer whose vaccination status does not match that expected on the basis of serological results * Positive blood pregnancy test on inclusion * Positive HCV, HIV or HDV test in a patient * Positive HBV, HCV, HIV or HDV test in a healthy volunteer
Where this trial is running
Limoges and 2 other locations
- Centre d'Investigation Clinique — Limoges, France (RECRUITING)
- Limoges University Hospital — Limoges, France (RECRUITING)
- Hospice civils de Lyon — Lyon, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Véronqiue LOUSTAUD-RATTI, MD — University Hospital, Limoges
- Study coordinator: Véronique LOUSTAUD-RATTI, MD
- Email: veronique.loustaud-ratti@unilim.fr
- Phone: +335 55 05 66 84
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.
Conditions: Chronic Hepatitis B Virus, HBV, NK celles, TLR9, B cells