The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
Alice Ho Miu Ling Nethersole Hospital
Tai Po, New Territories, Hong Kong
Queen Mary Hospital
Road, Hong Kong
Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
Safety: Laboratory tests, Adverse Events, Physical examination
Efficacy:
Viral kinetics of HBV DNA suppression
Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment
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