ongitudinal Characterization of Intrahepatic Immune Responses and Gene Expression Profiles in Patients with Viral Hepatitis. An investigator initiated single centre study.
- Conditions
- 1001965410047438chronic hepatitis B. chronic hepatitis C
- Registration Number
- NL-OMON45711
- Lead Sponsor
- Stichting Leveronderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
* Diagnosed with chronic HCV or chronic HBV
* Hepatitis C viral RNA detectable in case of chronic HCV infection or HBsAg positive for over 6 months in case of chronic HBV infection.
* Non-cirrhotic compensated liver disease.
* Age * 18 years and * 70 years.
* Written informed consent.
* Extensive bridging fibrosis indicated by histology (gold standard), imaging, transient elastography or 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the functionality of immune cells in the liver and blood in chronic<br /><br>HCV and chronic HBV patients before, and during or after treatment with<br /><br>antiviral treatment, as well as their gene expression profiles.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>