Gene Discovery in CHB Patients to Identify Unknown Pathways That Lead to B and NK Cell Deregulation
Recruiting · NCT06853886 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Limoges
View the official record on ClinicalTrials.gov →Interventions studied
blood sample HBV patientblood sample healthy volunteers
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
3 locations listed.
- Centre d'Investigation Clinique - Limoges, France
- Limoges University Hospital - Limoges, France
- Hospice civils de Lyon - Lyon, France