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This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Naïve Participants) | Experimental | Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks. |
|
| Group B (Conventional Interferon Pretreated Participants) | Experimental | Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks. |
|
| Group C (Lamivudine Pretreated Participants) | Experimental | Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL) | 72 weeks | |
| Percentage of participants with HBeAg seroconversion | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieved HBV DNA levels below limit of detection | Weeks 48 and 72 | |
| Number of participants with HBsAg loss | Weeks 48 and 72 | |
| Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs |
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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 |
|---|---|---|---|---|---|---|
| Beijing | 100011 | China | ||||
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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|
| Weeks 48 and 72 |
| Number of participants with alanine aminotransferase (ALT) normalization | Weeks 48 and 72 |
| Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization) | Weeks 48 and 72 |
| Incidence of adverse events | up to 72 weeks |
| Guangzhou |
| 510630 |
| China |
| Shanghai | 200025 | China |
| 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 |