The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Attached To The Capital Medical University
Beijing, Beijing Municipality, China
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
Time frame: Week 144
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
Time frame: Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Time frame: Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Time frame: Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Time frame: Week 48 & 96 & 144
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Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality, China
People's Hospital Under Beijnig University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Department of Infectious Disease, Nanfang Hospital
Guangzhou, Guangdong, China
GuangDong Provincial People's hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
...and 6 more locations