This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
100 mg/day
600 mg/day
University Hospital Ulm
Ulm, Germany
Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
Time frame: 2 weeks
Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy
Time frame: 12 weeks
Influence of HBeAg status to the decrease in viral load
Time frame: 12 weeks
Influence of HBV genotype to the decrease in viral load
Time frame: 12 weeks
Change in ALT and AST levels from Baseline to Week 12
Time frame: 12 weeks
Development of viral resistance and treatment failure during the study and subsequent course of observation
Time frame: 6 month
Safety assessed by adverse events and laboratory values
Time frame: 6 month
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