Chronic Hepatitis B
Conditions
Brief summary
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.
Interventions
DRUGClevudine
clevudine 30 mg qd for 24 seeks
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HBV DNA \> 2,000 copies/mL at screening * Patients who have compensated liver disease (Child-Pugh score =\<6) * Patients without LMV resistant mutation by RFMP assay * Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy * Patients who can submit the written consent and comply with the claims postulated of this clinical trial
Exclusion criteria
* Currently receiving antiviral except LMV or corticosteroid therapy * Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months * Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening * Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period * Patients who is co-infected with HCV, HDV or HIV * Serious concurrent medical conditions * Prior organ transplantation * Patient has creatinine clearance less than 60mL/min as estimated by the following formula: \[(140-age in years) (body weight \[kg\])\] / \[(72) (serum creatinine\] \[mg/dL\])\[Note: multiply estimates by 0.85 for women\]
Countries
South Korea
Outcome results
None listed