Characterization of immune responses in Hepatitis B patients experiencing a flare after stopping nucleot(s)ide analogue therapy

• Conditions: cHBV; Chronic hepatitis B; 10019654; 10047438

• Registration Number: NL-OMON50840
• Lead Sponsor: Stichting Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Age between 18 and 65.
• Previously diagnosed with chronic HBV.
• Treated with entecavir or tenofovir.
• Flare defined as ALT>=2x upper limit of normal.
• Written informed consent.

Exclusion Criteria

• 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>Determine the percentages of (NK cells, B cells, T cells, monocytes and MAIT<br /><br>cells) of the total lymphocyte population and the expression levels of the<br /><br>relevant activation and inhibitory markers as well as assessing their function<br /><br>and gene expression profile.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>