cHBV Chronic hepatitis B
Conditions
Interventions
None listed
Sponsors
Stichting Leveronderzoek
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age between 18 and 65. • Previously diagnosed with chronic HBV. • Treated with entecavir or tenofovir. • Flare defined as ALT>=2x upper limit of normal. • Written informed consent.
Exclusion criteria
Exclusion criteria: • Hepatic imaging (ultrasound, CT or MRI) with evidence of hepatocellular carcinoma. • Females who are pregnant or breast-feeding. • History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study. • Received prolonged therapy with immunomodulatory agents (e.g. corticosteroids) or biologics (e.g. monoclonal antibody, interferon) within 6 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the percentages of (NK cells, B cells, T cells, monocytes and MAIT cells) of the total lymphocyte population and the expression levels of the relevant activation and inhibitory markers as well as assessing their function and gene expression profile. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed