Prospective study on peripheral and intrahepatic immune cells derived from chronic hepatitis B patients during and after long-term treatment with direct antivirals
- Conditions
- chronic hepatitis B1001965410047438
- Registration Number
- NL-OMON49813
- Lead Sponsor
- Stichting Leveronderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 7
- man or woman, age of ><=18 and <<= 70 years
- chronic Hepatitis B (HBsAg positive for minimum 6 months)
- > 3 years on treatment with direct antivirals for CHB
- HBV DNA undetectable or < 60 IU/mL, on NA treatment for minimal 2 years
- HBeAg negative, while on NA treatment for minimal 2 year
- ALT < 1.5 ULN (by local assay), while on NA treatment for minimal 1 year and
at screening
- no evidence of cirrhosis
- HBV Genotype A, B, C, D or E
- otherwise healthy and medically stable
- written informed consent
- positive HIV test
- hepatitis A, C, D or E co-infection
- Subject had severe hepatitis activity (ALT >= 10xULN) while on NA(s)
treatment 2years before screening, or elevation ALT Level>1xULN 1 year before
screening and at screening
- decompensated cirrhosis or hepatocellular carcinoma (documented medical
history)
- Subject has an underlying condition which preclude the choice of direct
antivirals as treatment
- participation in another translational research study
- use of any investigational drug or use of an invasive investigational medical
device within 90 days before screening
- Subject has received immuno-modulating drugs (within 18 months prior to
screening) for HBV
- any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject
- major surgery (e.g. requiring general anaesthesia) within 12 weeks before
screening
- history of drug or alcohol abuse within 1 year before screening
- divers lab parameters (platelets, INR, bilirubin, Hb, eGFR, AFP)
- anticoagulation therapy or bleeding diathesis
- hemoglobinopathy
- pregnancy or breast-feeding
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The focus of the research is a comparison between all samples (cross-sectional<br /><br>and prospective study) of fine needle liver aspirates of patients at different<br /><br>chronic HBV infection phases with the aim to identify correlates between<br /><br>intrahepatic immune changes at the cellular or molecular level and viral<br /><br>control. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Multiple assessments are scheduled tor the same time point: vital signs,<br /><br>physical examinalion, blood collection tor safety, biochemica! and serological<br /><br>parameters, blood collection tor PBMC isolation, blood collection for serum and<br /><br>whole blood parameters and liver FNABs. Cells from blood and liver will be<br /><br>evaluated tor their phenotype by flow cytometry, and for their gene expression<br /><br>by RNA sequencing.</p><br>