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

Exclusion Criteria

• •1. Patients with HBV DNA \< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
• •2. Patients with HBV DNA \< 4,700 copies/mL and ALT normalization in L-FMAU-302
• •3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
• •4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
• •5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
• •6. Patient is coinfected with HCV, HDV or HIV.
• •7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein \> 50 ng/mL
• •8. Patient is pregnant or breast-feeding.
• •9. 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)
• •10. Patient has a clinically relevant history of abuse of alcohol or drugs.
• •11. 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.
• •12. 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