Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

Inclusion Criteria: Patient is between 18 and 60, inclusive Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302. Patient has bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL at week 48 in L-FMAU-301 or L-FMAU-302. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening. Patient is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301 Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302 Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is coinfected with HCV, HDV or HIV. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein > 50 ng/mL 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. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence) Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor. 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] 13.Patient whom investigator consider is not suitable in this study