Status:
UNKNOWN
Mechanism of DCs Dysfunction in Chronic HBV Infection
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Etablissement Français du Sang
Conditions:
HBV
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Currently, chronic hepatitis B virus (HBV) infection therapies are limited to pegylated interferon alpha (Peg-IFNα) and nucleos(t)ide analogues (NUCs), alone or in combination. Even though they can re...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Group 1a: HBV positive patients / no scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- HBsAg positive for more than 6 months
- known status of HBeAg (positive or negative)
- Treated or not with an antiviral
- Group 1b: HBV positive patients / with scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- HBsAg positive for more than 6 months
- known status of HBeAg (positive or negative)
- Treated or not with an antiviral
- Patient with a liver biopsy indication as part of the treatment within 3 months.
- Group 2: NASH patients / with scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- The existence of at least one element of metabolic syndrome
- Steatosis detected by non-invasive tests (echo, CAP, MRI)
- Group 3: Blood samples from healthy donors
- No subject will be included in this group, the samples have been already collected at EFS from healthy donors who had previously given their informed consents for using their blood samples in the research.
- The blood samples have been collected in sufficient quantity to carry out the analyzes (20mL from each donor).
- Exclusion Criteria:
- For groups 1a, 1b and 2 (HBV or NASH patients):
- Positive serology for HCV, HDV, HTLV, HIV
- Active autoimmune diseases
- Immunosuppressive therapies
- Cancer \<2 years
- Alcohol: male\> 30g / day, female\> 20g / day
- Group 1a and 1b:
- NASH patients
- Group 2:
- Positive HBsAg Group 3: Blood samples from healthy donors
- Positive serology for HCV, HTLV, HIV, HBV (in the sense of a positive HBsAg test).
- Risk of any infectious disease at the time of sample collection (including fever\> 38 ° C over the past 15 days or recent contact with a person with a contagious disease).
- Autoimmune disease or immunosuppressive therapy at the time of sample collection.
Exclusion
Key Trial Info
Start Date :
December 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03753308
Start Date
December 5 2018
End Date
December 31 2022
Last Update
September 1 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Grenoble Alpes
Grenoble, France, 38043