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Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | Clevudine flexible dosages of 30 mg/day |
| |
| Adefovir |
| Measure | Description | Time Frame |
|---|---|---|
| Value of log10 hepatitis B virus (HBV) DNA decreases form baseline. | 48 weeks | |
| Histological response | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay. | 48 weeks | |
| Percent of patients with normalization of alanine aminotransferase (ALT) at week 48 | 48 weeks |
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Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Guoping Yang | Xiangya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya hospital | Changsha | Hunan | 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 |
|---|---|
| C034935 | clevudine |
| C053001 | adefovir |
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| Drug |
Adefovir flexible dosages of 10 mg/day |
|
| 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 |