This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52
Time frame: Baseline and Week 52
Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52
The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52
Time frame: Week 52
Time to Onset of HBV DNA Loss (< 400 Copies/mL)
Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0
Time frame: From Baseline to Week 52
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52
Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method
Time frame: Week 52
Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52
Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method
Time frame: Week 52
Time to Onset of HBeAg Loss
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Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.
Time frame: From Baseline to Week 52
Time to Onset of HBeAg/Ab Seroconversion
Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.
Time frame: From Baseline to Week 52
Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52
Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method
Time frame: Week 52
Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52
Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method
Time frame: Week 52
Mean Alanine Aminotransferase (ALT) Level at Week 52
Summary statistics were displayed for serum ALT.
Time frame: Week 52
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52
ALT normalization was defined as an ALT value that was in the normal range (\<= 45IU/L; upper limit of normal \[ULN\]) at Week 52 of the participants whose ALT values were abnormal (\>45IU/L) at baseline
Time frame: Week 52
Time to Onset of ALT Normalization
Time to onset of ALT normalization was summarized using the Kaplan-Meier method.
Time frame: From Baseline to Week 52
Rate of Emergence of Resistant Virus at Week 52
Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene
Time frame: Week 52