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Mechanism of DCs Dysfunction in Chronic HBV Infection

NCT03753308 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2020-09-01

No results posted yet for this study

Summary

This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms by which the immune response is altered by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity

Conditions

  • HBV
  • NASH - Nonalcoholic Steatohepatitis

Interventions

BIOLOGICAL

Blood Sampling

5 x Lithium Heparin Tubes WITHOUT DARK GREEN GEL, 5 ml- v. 4 ml Blood volumes collected as part of the usual care and this research comply with the recommendations of Jarde's law for an observational study (less than 80 ml in one day and less than 160 ml over 30 consecutive days for a subject over 40kg).

BIOLOGICAL

Liver biopsy

The liver biopsy is part of the usual care and it follows the usual procedure of CHUGA: The patient is placed in a supine position and received a transitory sedation, MEOPA gas (Kalinox®). Also, an ultrasound scan is performed. Local disinfection followed by local anesthesia with Xylocaine® are performed. The biopsy is performed with the Hepafix 17 gauge needle. 1 passage is carried out to obtain a biopsy fragment of at least 20 mm for the diagnosis (if the passage is unsuccessful, a second passage can be performed strictly as part of the usual care and not as part of research). If the biopsy is\> 20 mm, a fragment of the excess biopsy specimen (10% or 2 mm) will be cut and used for research in groups 1b and 2. This division is performed by the clinician directly on the fresh specimen

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Etablissement Français du Sang

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Vincent LEROY, Pr · CHU Grenoble Alpes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2021-12-05
Completion
2022-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753308 on ClinicalTrials.gov