An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Nucleoside-analogue naive patient : Clevudine 30mg qd 1. Assess the complete virological response(HBV DNA \< 60 IU/ml) at 24 weeks: Only Clevudine 30mg qd 2. Assess not the complete virological response at 24 weeks : Add Adefovir 10mg qd 3. During medication of Clevudine, virological breakthrough : add adefovir 10mg qd 4. During treatment period, composite virological response : stop the medication and F/U for 2 years 5. Recurrence after stopping treatment(HBV DNA \> 2,000IU/ml) retreat medication at composite virological response. * complete virological response: HBV DNA \< 60 IU/ml * virological breakthrough : During antiviral treatment, HBV DNA increased from nadir to 1 log10IU/ml continuously.
Seoul National University Hospital
Seoul, South Korea
Proportion of patients with HBV DNA levels < 60 IU/mL
Time frame: 48 week
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