Cross-sectional study on peripheral and intrahepatic immune cells derived from chronic hepatitis B patients not on treatment

Completed

Conditions: chronic hepatitis B
10019654
10047438

Registration Number: NL-OMON50279

Lead Sponsor: Stichting Leveronderzoek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

- man or woman, age of ><=18 and <<= 70 years
- chronic Hepatitis B (HBsAg positive for minimum 6 months)
- no evidence of cirrhosis
- HBV Genotype A, B, C, D or E
- otherwise healthy and medically stable
- written informed consent
- not on treatment for CHB
- disease stage specific ALT, HBeAg and HBV DNA (according to protocol)

Exclusion Criteria

- positive HIV test
- hepatitis A, C, D or E co-infection
- decompensated cirrhosis or hepatocellular carcinoma (documented medical
history)
- participation in another translational research study or clinical study
- use of any investigational drug or use of an invasive investigational medical
device within 90 days before screening
- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Per visit max.175 ml of peripheral blood and fine needle aspirate biopsies<br /><br>(FNAB) will be collected. Multiple assessments are scheduled for the same time<br /><br>point: vital signs, physical examination, blood collection for safety,<br /><br>biochemical and serological parameters, blood collection for PBMC isolation,<br /><br>blood collection for serum and whole blood parameters and liver FNABs. Cells<br /><br>from blood and liver will be evaluated for their phenotype by flow cytometry,<br /><br>and for their gene expression by RNA sequencing.</p><br>

Secondary Outcome Measures