A Phase 3 interventional study of Clevudine in Hepatitis B, sponsored by Bukwang Pharmaceutical. Completed at 2 sites in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-26.
Sponsored by Bukwang Pharmaceutical · Phase 3, Interventional, and Treatment
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 92 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Bukwang Pharmaceutical is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Bukwang Pharmaceutical