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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 4
Accepts Healthy Volunteers?
Lead Sponsor:
Bukwang Pharmaceutical
Adefovir dipivoxil
Antiviral Agents
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 ≥ 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

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

- 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

- 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 α-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]