Chronic hepatitis Delta viral liver inflammation Viral liver inflammation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Active hepatitis delta based on a positive anti-HDV or a positive HDV-RNA test - Patients must be >=18 years and <= 70 years. - Non-cirrhotic or cirrhotic compensated liver disease - Patients must be able to provie a written informed consent
Exclusion criteria
Exclusion criteria: • Clinical decompensated cirrhosis (Child-Pugh Grade B or C). • 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. • Thrombocytes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The immuno-phenotype of CD4+ T cells, CD8+ T cells, monocytes/macrophages, neutrophils, NK cells, NKT cells, MAIT cells, and B cells will be assessed in blood and liver of patients chronic HBV-HDV. The function of CD4+ T cells, CD8+ T cells, monocytes/macrophages, neutrophils, NK cells, NKT cells, MAIT cells, and B cells will be assessed in blood. Gene expression profiles of immune cells and hepatocytes in blood and liver of patients will be assessed. | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam