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Active, not recruiting Not applicable

NK Cell Deregulation in HBV Patients

NCT03761875 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2018-12-11
Last updated
2026-06-26

Condition(s) studied

Hepatitis B Virus

Investigational drug(s) / intervention(s)

blood sample CHB patientsboold sample Control group

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

boold sample Control group: * 2 tubes EDTA ideally age and sex matched to CHB patient. * 1 tube "Paxgene" 1ml * 1 dry tube

Study summary

Natural Killer (NK) cells play a large role in the innate immune response as they are equipped to kill infected or tumor cells. They express a panel of activating and inhibitory receptors that regulate the destruction of the target cell. Many reports have shown that NK cell function is suppressed in CHB patients. Exhaustion occurs when activating receptors become over stimulated leading to the loss of NK function. The investigators hypothesize that NK cells are rendered dysfunctional/ exhausted by HBV. The primary objective is to determined the phenotypical modifications and mechanisms associated to NK cell dysfunction, during different phases of CHB infection, in not treated patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this study: * Male or female, age ≥18 years * HBV infection or chronic HBV infection * Willing and able to provide written informed consent Healthy donors must meet all of the following inclusion criteria to be eligible for participation in this study: * Male or female, age between 18 and 50 years * Willing and able to provide written informed consent Exclusion Criteria: * Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: * Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) * Chronic liver disease of a non-HBV etiology * Immune or cancerous disease

Primary outcome measure(s)

  • Using a multiparameter flow cytometry approach, we will assess the mean fluorescence intensity (MFI) of the listed molecules expressed on Natural Killer cells — At inclusion, day 0

Trial sites (1)

FacilityCityRegionStatus
Limoges Hospital Limoges France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03761875 on ClinicalTrials.gov ↗ ← All trials in France