HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Conditions
Brief 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.
Interventions
DRUGClevudine
30mg for 48 weeks
DRUGAdefovir dipivoxil
10mg for 48 weeks
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HBV DNA below 300copies/mL | at week 48 |
Secondary
| Measure | Time frame |
|---|---|
| The change of HBV DNA from the baseline | at week 24, 48 |
| Proportion of patients with HBV DNA below LOD of RT-PCR | at week 24, 48 |
| ALT normalization rate | at week 24, 48 |
| Proportion of patients with viral breakthrough during 48-week treatment period | at week 24, 48 |
Countries
South Korea
Outcome results
None listed