Prospective study on peripheral and intrahepatic immune cells derived from chronic hepatitis B patients during and after long-term treatment with direct antivirals

Prospective study on peripheral and intrahepatic immune cells derived from chronic hepatitis B patients during and after long-term treatment with direct antivirals - HBV-FNAB-002 study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49813

Enrollment

Registered

2019-12-17

Start date

2020-03-10

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - man or woman, age of > 3 years on treatment with direct antivirals for CHB - HBV DNA undetectable or

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
The focus of the research is a comparison between all samples (cross-sectional and prospective study) of fine needle liver aspirates of patients at different chronic HBV infection phases with the aim to identify correlates between intrahepatic immune changes at the cellular or molecular level and viral control.	—

Secondary

Measure	Time frame
Multiple assessments are scheduled tor the same time point: vital signs, physical examinalion, blood collection tor safety, biochemica! and serological parameters, blood collection tor PBMC isolation, blood collection for serum and whole blood parameters and liver FNABs. Cells from blood and liver will be evaluated tor their phenotype by flow cytometry, and for their gene expression by RNA sequencing.	—

Measure

Time frame

Multiple assessments are scheduled tor the same time point: vital signs, physical examinalion, blood collection tor safety, biochemica! and serological parameters, blood collection tor PBMC isolation, blood collection for serum and whole blood parameters and liver FNABs. Cells from blood and liver will be evaluated tor their phenotype by flow cytometry, and for their gene expression by RNA sequencing.

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Countries

Netherlands

Outcome results