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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sample HBV patient

    Other intervention

    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

  • blood sample healthy volunteers

    Other intervention

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: HBV patientOther 1 intervention
Group B: healthy volunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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)

Time frame
At inclusion, day 0

Other outcomes

Sponsors and contacts

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University Hospital, Limoges

Lead sponsor

National Agency for Research on AIDS and Viral Hepatitis (ANRS)

Collaborator