Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
anti-viral therapy
antiviral and antifibrosis therapy
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Regression of HBV-induced liver cirrhosis
Liver cirrhosis regression of 1 point by Ishak scoring system
Time frame: 1.5 to 2 years
Child-Pugh score
Child-Pugh score change after 1 and 2-year treatment
Time frame: 1 year and 2 years
HBVDNA undetectable rate
The HBVDNA undetectable rate after 1 and 2-year treatment.
Time frame: 1 year and 2 years
Fibroscan value
Fibroscan value change after 1 and 2-year treatment
Time frame: 1 year and 2 years
Life Quality
Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Time frame: 1 year and 2 years
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