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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50279
Enrollment
45
Registered
2017-07-28
Start date
2019-03-06
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

None listed

Sponsors

Stichting Leveronderzoek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - man or woman, age of >

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)