Status:
RECRUITING
Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocell...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years of age)
- Patients chronically infected with hepatitis B virus at any stage of infection
- Nucleoside Analogues-treated or untreated
- Co-infected or not with HDV
- Included in the prospective CirB-RNA study (part of the CirB-RNA university research program) (ID-RCB : 2018-A02558-47, NCT03825458)
- Patient informed of the study and having signed a consent form
Exclusion
- Pregnant, parturient or breast-feeding women,
- Patients with decompensated cirrhosis
- Patients with hepatocellular carcinoma (suspected or proven),
- Liver transplant patients (even if liver transplantation for HBV),
- Patients co-infected with HCV (positive serum viral load) and/or HIV (regardless of serum viral load).
- Patients participating at the time of inclusion in an interventional study
- Persons under psychiatric care,
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (legal guardianship, tutorship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme.
- Patients with abdominal skin lesions and/or infections.
- Contraindication to lidocaine administration (allergy or hypersensitivity to the product).
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 8 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06047093
Start Date
March 8 2024
End Date
March 8 2028
Last Update
November 26 2024
Active Locations (1)
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1
Hepatology Department - Hospices Civils de Lyon
Lyon, France, 69004