Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
606
anti-viral therapy
anti-viral and antitherapy
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Decompensated rate of Liver Cirrhosis after 2 years treatment
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.
Time frame: 2 years
Child-Pugh and MELD scores
The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
Time frame: 1 and 2-year
The HBV DNA undetectable rate
The HBV DNA undetectable rate after 1 and 2-year treatment
Time frame: 1 and 2-year
Liver stiffness measurement
Liver stiffness measurement change after 1 and 2-year treatment.
Time frame: 1 and 2-year
Quality of Life
Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares
Time frame: 1 and 2-year
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