Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

Exclusion Criteria

• •1. HBV DNA negative (\< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
• •2. Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
• •3. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
• •4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
• •5. Patient is coinfected with HCV, HDV or HIV.
• •6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
• •7. Patient is pregnant or breast-feeding.
• •8. 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), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence)
• •9. Patient has a clinically relevant history of abuse of alcohol or drugs.
• •10. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
• •11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula:
• •(140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]