A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Conditions
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HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Intervention / Treatment
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* Drug: Clevudine
* Drug: Adefovir dipivoxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is between 18 and 60 Patient is documented to be HBsAg positive for > 6 months. Patient with compensated hepatic function. Nucleoside treatment-naÃ-ve subjects of either gender Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels â‰¥ 1 x 10(5) copies/mL within 30 days of baseline. Patient has ALT levels which are in the range of 2 x ULN and < 10 X ULN Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy. 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 Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease 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 Î±-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]

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Clevudine | Drug: Clevudine<br>* 30mg for 48 weeks<br>* Other names: Levovir;|
| Active Comparator: 2<br>Adefovir | Drug: Adefovir dipivoxil<br>* 10mg for 48 weeks<br>* Other names: Hepsera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBV DNA below 300copies/mL |  | at week 48 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | at week 24, 48 | 
| Proportion of patients with viral breakthrough during 48-week treatment period |  | at week 24, 48 |