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This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection period for each patients will occur in the first 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry) | 24 weeks | |
| CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry) | 24 weeks | |
| CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture | 24 weeks | |
| CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation | 24 weeks | |
| CD8 response in HLA-A2 positive patients | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of proinflammatory cytokines: analysis of cytokines in serum | 24 weeks | |
| HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bologna | 40138 | Italy | ||||
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| Brescia |
| 25125 |
| Italy |
| Milan | 20122 | Italy |
| Parma | 43100 | Italy |
| Reggio Emilia | 42100 | Italy |
| 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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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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