Finding gene changes in chronic hepatitis B that cause B cell and NK cell dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre d'Investigation Clinique
  Limoges, France Recruiting
• Limoges University Hospital
  Limoges, France Recruiting
• Hospice civils de Lyon
  Lyon, France Recruiting

Study contacts

• Principal investigator: Paul CARRIER, MD — University Hospital, Limoges
• Study coordinator: Paul CARRIER, MD
• Email: paul.carrier@chu-limoges.fr
• Phone: +335 55 05 80 22

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.