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This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adefovir dipivoxil | Drug | 10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of ALT, and HBV-DNA <400 copies/mL | Week 96 for arm 1; week 48 for arms 2 and 3 | |
| HBsAg quantitative loss and anti-HBs seroconversion | Weeks 48, 96 and 144 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, lab parameters, vital signs | Throughtout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara | 06018 | Turkey (Türkiye) | ||||
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| peginterferon alfa-2a [Pegasys] |
| Drug |
180 micrograms weekly for 48 weeks |
|
| Ankara |
| 06100 |
| Turkey (Türkiye) |
| Ankara | 06500 | Turkey (Türkiye) |
| Ankara | 06800 | Turkey (Türkiye) |
| Gaziantep | 27310 | Turkey (Türkiye) |
| 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 |
|---|---|
| C106812 | adefovir dipivoxil |
| C100416 | peginterferon alfa-2a |
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