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The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamivudine plus Adefovir or Adefovir | Active Comparator | Lamivudine+Adefovir or Adefovir for 48 weeks |
|
| Entecavir plus Adefovir | Experimental | Entecavir+Adefovir for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug | Lamivudine 100mg/day orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV DNA<15IU/mL | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV DNA<15IU/mL | Day1, week12, week 24, week 36, week 48 | |
| The change of HBV DNA from the baseline | week 48 | |
| Proportion of patients with ALT normalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danbi Lee | Contact | 82)2-3010-3907 | leighdb@hanmail.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Adefovir |
| Drug |
Adefovir 10mg/day orally |
|
| Entecavir | Drug | Entecavir 1mg/day orally |
|
| Day1, week12, week 24, week 36, week 48 |
| Proportion of patients with HBeAg loss and/or seroconversion | Day1, week12, week 24, week 36, week 48 |
| The change of HBsAg from the baseline | week 48 |
| Proportion of patients with HBsAg loss and/or seroconversion | week 24, week 48 |
| Proportion of patients who experienced virologic breakthrough | week 48 |
| Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs) | Composite outcome measure consisting of multiple measures, including:
| week 48 |
| 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 |
|---|---|
| D019259 | Lamivudine |
| C053001 | adefovir |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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