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This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Blood samples from healthy volunteers will be collected for ex vivo stimulation and for further sample preparation and analysis. | ||
| Nucleoside/nucleotide analogue-treated CHB patients | Blood samples from nucleoside/nucleotide analogue-treated CHB patients will be collected for ex vivo stimulation and for further sample preparation and analysis. | ||
| Treatment-naive CHB patients | Blood samples from treatment-naïve CHB patients will be collected for ex vivo stimulation and for further sample preparation and analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation coefficients between baseline toll-like receptor 7 (TLR7) expression and ex vivo immune response upon stimulation of PBMCs with RO6871765 or RO7011785 (in terms of cytokine release and gene expression) | Day 1 | |
| Cytokine/chemokine production | Day 1 | |
| Induction of interferon-responsive genes | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number or percentages of T-lymphocytes in healthy volunteers and subjects with CHB | Screening Up to Day 1 | |
| Number or percentages of B-lymphocytes in healthy volunteers and subjects with CHB | Screening up to Day 1 |
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Inclusion Criteria:
All population:
Healthy volunteers:
Treatment naïve CHB patients:
HBeAg-negative nucleoside/nucleotide analogue-treated CHB patients:
Exclusion Criteria:
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Chinese population: healthy volunteers, treatment naive CHB patients and nucleoside or nucleotide analogue treated CHB patients
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai | 200025 | China | ||||
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| Number or percentages of natural killer (NK) -cells in healthy volunteers and subjects with CHB | Screening up to Day 1 |
| Number or percentages of myeloid dendritic cells (mDCs) in healthy volunteers and subjects with CHB | Screening up to Day 1 |
| Number or percentages of plasmacytoid dendritic cells (pDCs) in healthy volunteers and subjects with CHB | Screening up to Day 1 |
| Ex-vivo antiviral activity of PBMC supernatant | Day 1 |
| Shanghai |
| 200433 |
| China |
| Shanghai | 201203 | China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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