Chronic Hepatitis B
Conditions
Keywords
Clevudine, efficacy, safety, chronic hepatitis B
Brief summary
Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
Interventions
DRUGClevudine
Clevudine flexible dosages of 30 mg/day
DRUGAdefovir
Adefovir flexible dosages of 10 mg/day
Sponsors
Eisai Co., Ltd.
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 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are between 18 and 65, inclusive. 2. All the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study. 3. Hepatitis B virus Early Antigen (HBeAg) positive patient with HBV DNA \>1 x 105 copies/ml, HBeAg negative patient with HBV DNA \>1 x 104 copies/ml within 30 days of baseline. 4. Absolute neutrophil count \> 1500 /mm3. 5. Alpha fetoprotein within normal laboratory limit at screening. 6. Normal electrocardiogram (ECG) or clinically non-significant changes at screening. 7. Able to participate and willing to give written informed consent before starting therapy. 8. Able and willing to comply with study assessments and restrictions. 9. Normal renal function to take Adefovir without any dose modifications; Creatinine clearance must be \>50 ml/min (based on the Cockcroft-Gault equation.
Exclusion criteria
1. Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus 2. Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration. 3. Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease. 4. Poorly controlled type I or type 2 diabetes mellitus 5. Donation or loss more than 400 ml blood within 60 days of baseline. 6. Known serious allergies to nucleoside/nucleotide analogs. 7. Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Value of log10 hepatitis B virus (HBV) DNA decreases form baseline. | 48 weeks |
| Histological response | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay. | 48 weeks |
| Percent of patients with normalization of alanine aminotransferase (ALT) at week 48 | 48 weeks |
Countries
China
Outcome results
None listed