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A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Clevudine |
|
| 2 | Active Comparator | Adefovir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | 30mg for 48 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV DNA below 300copies/mL | at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of HBV DNA from the baseline | at week 24, 48 | |
| Proportion of patients with HBV DNA below LOD of RT-PCR | at week 24, 48 | |
| ALT normalization rate |
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Inclusion Criteria:
Exclusion Criteria
Patient is currently receiving antiviral or corticosteroid therapy.
Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, famciclovir or any other investigational nucleoside for HBV infection.
Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
Patient is coinfected with HCV, HDV or HIV.
Patient with following clinical evidence
Previous organ transplantation
Patient has a clinically relevant history of abuse of alcohol or drugs.
Patient is pregnant or breast-feeding.
Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
Patient has α-Fetoprotein more than 100ng/mL
Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 3,500/mm3 (PMN<1,500/mm3) or Platelet count <50,000/mm3
Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | South Korea | ||||
| Seoul National University Hospital |
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| Adefovir dipivoxil |
| Drug |
10mg for 48 weeks |
|
|
| at week 24, 48 |
| Proportion of patients with viral breakthrough during 48-week treatment period | at week 24, 48 |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| C034935 | clevudine |
| C106812 | adefovir dipivoxil |
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