Characterization of intrahepatic immune responses and gene expression profiles in patients with chronic hepatitis Delta
- Conditions
- 1001965410047438Chronic hepatitis Deltaviral liver inflammation
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
- Active hepatitis delta based on a positive anti-HDV and 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
• 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 < 60x109/L
• Inability to provide written informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The immuno-phenotype of CD4+ T cells, CD8+ T cells, monocytes/macrophages,<br /><br>neutrophils, NK cells, NKT cells, MAIT cells, and B cells will be assessed in<br /><br>blood and liver of patients chronic HBV-HDV.<br /><br><br /><br>The function of CD4+ T cells, CD8+ T cells, monocytes/macrophages, neutrophils,<br /><br>NK cells, NKT cells, MAIT cells, and B cells will be assessed in blood.<br /><br><br /><br>Gene expression profiles of immune cells and hepatocytes in blood and liver of<br /><br>patients will be assessed. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>