The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
GSK Investigational Site
Guangzhou, Guangdong, China
GSK Investigational Site
Guangzhou, Guangdong, China
GSK Investigational Site
Changchun, Jilin, China
GSK Investigational Site
Jinan, Shandong, China
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
Time frame: Week 12
The proportion of subjects with ALT normalisation
Time frame: Week 52, 104, 156, 208, 260
log10 reduction in serum HBV DNA
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg loss
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg seroconversion
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance
Time frame: Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA undetectable (<300 copies/mL)
Time frame: Week 52, 104, 156, 208, 260
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GSK Investigational Site
Hangzhou, Zhejiang, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Chongqing, China
GSK Investigational Site
Chongquin, China
GSK Investigational Site
Shanghai, China