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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017602-36 |
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This study was canceled for operational reasons.
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This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Experimental |
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| C | Placebo Comparator |
| |
| D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| entecavir | Drug | 0.5 mg orally daily, 24 weeks (weeks 12-36) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml) | 48 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation early HBsAg response - response end of treatment/follow-up | every 6 weeks up to week 48, every 12 weeks therafter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| peginterferon alfa-2a [Pegasys] |
| Drug |
180 mcg sc weekly, 48 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly, 96 weeks |
|
| placebo | Drug | orally daily, 24 weeks (weeks 12-36) |
|
| 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 |
|---|---|
| C413685 | entecavir |
| C100416 | peginterferon alfa-2a |
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