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

Bukwang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Treatments

Drug: Adefovir dipivoxil

Drug: Clevudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00641082

CLV-401

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 â‰¥ 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 Î±-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]