This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b
Chronic hepatitis b (CHB) remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGRate of renal function decline
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
Time frame: 144 week
Rate of hypercalcemia
The serum calcium would be detected to know the ratio of patients with hypercalcemia.
Time frame: 144 week
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value.
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b e antigen loss rate
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value.
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b e antigen seroconversion rate
hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
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