NK Cell Deregulation in HBV Patients
LiNKeB
1 other identifier
interventional
80
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedStudy Start
First participant enrolled
December 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 6, 2023
May 1, 2023
5 years
November 12, 2018
May 4, 2023
Conditions
Keywords
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
OTHERa blood sample is done during a follow-up visit
Control group
OTHERa blood sample
Interventions
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
* 2 tubes EDTA ideally age and sex matched to CHB patient. * 1 tube "Paxgene" 1ml * 1 dry tube
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Limoges Hospital
Limoges, 87 042, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Véronique LOUSTAUD-RATTI, MD
Limoges Hospital
- STUDY DIRECTOR
Uzma HASAN
Inserm U1111, Lyon
Central Study Contacts
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
December 1, 2023
Study Completion
March 1, 2024
Last Updated
May 6, 2023
Record last verified: 2023-05