NK Cell Deregulation in HBV Patients

NCT03761875 | Active Not Recruiting

• 1 other identifier: 87RI18-0021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis B Virus

Keywords

Hepatitis B Virus - Natural Killer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CHB patients

OTHER

a blood sample is done during a follow-up visit

Other: blood sample CHB patients

Control group

OTHER

a blood sample

Other: boold sample Control group

Interventions

blood sample CHB patients OTHER

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

CHB patients

boold sample Control group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥18 years
• HBV infection or chronic HBV infection
• Willing and able to provide written informed consent
• Male or female, age between 18 and 50 years
• Willing and able to provide written informed consent

You may not qualify if:

• Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
• Chronic liver disease of a non-HBV etiology
• Immune or cancerous disease

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges Hospital

Limoges, 87 042, France

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Véronique LOUSTAUD-RATTI, MD

  Limoges Hospital

  PRINCIPAL INVESTIGATOR

• Uzma HASAN

  Inserm U1111, Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 3, 2018
• Study Start: December 11, 2018
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

FR (1)