Chronic Hepatitis B (CHB) infection
Conditions
Interventions
Drug (interventional parent trial with Bepirovirsen)
this sub-study is observational using biological samples.
Brief methodology of the parent trial:
The parent trial is a Phase 2b randomized controlled study (B-Well) evaluating Bepirovirsen, an antise
Sponsors
Chang Gung Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults with chronic hepatitis B enrolled in the Bepirovirsen-based B-Well trial 2. Provided informed consent for optional immunologic sub-study 3. Available peripheral blood mononuclear cell (PBMC) and plasma samples collected at predefined time points
Exclusion criteria
Exclusion criteria: 1. Hemoglobin < 10 g/dL 2. Withdrawal of consent for B-Well sub-study 3. Insufficient sample quality or quantity for immune analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-specific CD8 T-cell phenotype measured using multicolor flow cytometry (Symphony) and single-cell RNA sequencing of PBMC samples at baseline (before IP/placebo), Week 7–10, Week 21–23 (end of IP treatment), and Week 40–46 (24 weeks post-treatment follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Innate-like CD8 T-cell frequency and activation status (CD38?HLA-DR? CD8 T cells) measured by flow cytometry and scRNA-seq at baseline, Week 7–10, Week 21–23 and Week 40–46. 2. Innate immunity status measured by flow cytometry and scRNA-seq at baseline, Week 7–10, Week 21–23 and Week 40–46. 3. Plasma cytokines (IL-12, IL-15, IL-18) measured by BD Cytometric Bead Array at baseline, Week 7–10, Week 21–23 and Week 40–46. | — |
Countries
Taiwan
Contacts
Public ContactWen-Juei;Chun-Yen Jeng;Lin
;
Outcome results
None listed