Chronic Hepatitis B Clinical Trial
Official title:
A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir
The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.
Lamivudine with adefovir combination therapy has been known as effective antiviral therapy
for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir
monotherapy since the incidence of viral breakthrough of combination therapy used to be less
than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients.
Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural
beta-L configuration that has potent activity against HBV. It has demonstrated potent
antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We
hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant
patients might be as effective as the lamivudine plus adefovir combination therapy.
In detail, we designed to perform this clinical study comparing the combination of clevudine
and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B
patient. Total treatment duration of both groups will be 12 months, and compare the efficacy
of antiviral effects of these drugs.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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