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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bukwang Pharmaceutical
• Treatments: Adefovir; Adefovir dipivoxil; Antiviral Agents; Clevudine

Criteria

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 encephalopathy.

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 infection.

• 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 carcinoma

• 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]