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The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR | ||
| Safety: Laboratory tests, Adverse Events, Physical examination |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: | ||
| Viral kinetics of HBV DNA suppression | ||
| Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George KK Lau, M.D. | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Nancy Leung, M.D. | Alice Ho Miu Ling Nethersole Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alice Ho Miu Ling Nethersole Hospital | Tai Po | New Territories | Hong Kong | |||
| Queen Mary Hospital |
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| Label | URL |
|---|---|
| Unique trial number : HKCTR-250 | View source |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C034935 | clevudine |
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| Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period |
| Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment |
| Road |
| Hong Kong |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |