A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 Mg QD in Patients With HBeAg Negative Chronic Hepatitis B
1. Patients who were between 18 and 60, inclusive
2. Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
3. Patients who were documented to be HBsAg positive for > 6 months (documentation of
positive HBsAg for the previous 6 months included previous laboratory reports showing
HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and
IgG anti-HBc positive at screening).
4. Patients who were HBeAg negative and HBeAb positive.
5. Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper
limit of normal (ULN) and 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.
6. Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken
within 14 days of starting therapy.
7. Patients who were able to give written informed consent prior to study start and to
comply with the study requirements.
1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid
2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any
other investigational nucleoside for HBV infection. Previous treatment with
interferon that had ended less than 6 months prior to the screening visit.
3. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
4. Patients coinfected with HCV, HDV or HIV.
5. Patients with clinical evidence of liver mass or with -fetoprotein > 50 ng/mL
6. Patients who were pregnant or breast-feeding.
7. Patients who were unwilling to use an “effective” method of contraception during the
treatment period and for up to 3 months after cessation of therapy. For males,
condoms should be used. Females had to 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
8. Patients with a clinically relevant history of abuse of alcohol or drugs.
9. Patients with a significant gastrointestinal, renal, hepatic (decompensated),
broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological,
cardiovascular, oncologic or allergic disease. The patient with a benign tumor was
excluded if judged by an investigator that the continuation of study would be
interfered by benign tumor.
10. Patients with creatinine clearance less than 60mL/min as estimated by the following
(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply
estimates by 0.85 for women]