The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
patients will receive oral entecavir 1mg, daily for 104 weeks.
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Beijing Ditan Hospita
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, China
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
Time frame: week 104
serum HBV DNA reduction from baseline at week 104
Time frame: week 104
The proportion of subjects with ALT normalization at week 104
Time frame: week104
The proportion of subjects with HBeAg loss and seroconversion at week 104
Time frame: week104
The proportion of subject with HBsAg loss and seroconversion at week 104
Time frame: week104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
Time frame: week104
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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