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This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) | approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| HBs levels in correlation with treatment outcome | approximately 2.5 years | |
| For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis B initiated on therapy with Pegasys
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bytom | 41-902 | Poland | ||||
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| approximately 2.5 years |
| For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization | approximately 2.5 years |
| Safety: Incidence of adverse events | approximately 2.5 years |
| Dębica |
| 39-200 |
| Poland |
| Gdansk | 80-214 | Poland |
| Krakow | 31-202 | Poland |
| Krakow | 31-501 | Poland |
| Mysłowice | 41-400 | Poland |
| Racibórz | 47-400 | Poland |
| Wroclaw | 51-149 | Poland |
| Łańcut | 37-100 | Poland |
| 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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