To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis B patients.
Chronic hepatitis B (CHB) affects approximately 360 million persons worldwide and is the most common cause of liver disease and affects over 10% of the general population in China. Hepatic steatosis is the main hepatic presentation of non- alcoholic fatty liver disease that is becoming another important liver disorder both in China and worldwide with economic development. It would be expected that hepatic steatosis might occur in CHB patients and recent studies show the frequency of steatosis in CHB ranges from 27% to 51%. However, the effect of steatosis on the anti-viral treatment in CHB patients is still vague. The aim of this RCT is to investigate the effect of steatosis on the therapeutic effect of entecavir in chronic hepatitis B patients. We will compare the anti-viral effect of entecavir among four groups: CHB group with entecavir therapy, CHB + steatosis group with entecavir therapy, CHB + steatosis group with entecavir + essentiale therapy and CHB + steatosis group with entecavir + vitamin E therapy. The speculated points are set as 3 months, 12 months and 15 months. Liver biopsy will be carried out at beginning and the 12th month. Other serum biochemical and viral markers are recorded as well as CT or ultrasound scan are repeated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,200
The first affiliated hospital, college of medicine, zhejiang university
Hangzhou, Zhejaing, China
RECRUITINGDifferences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs
The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis and changes in the histological features of liver biopsy(steatosis degree, inflammation and fibrosis).
Time frame: 12 months
Differences in the sustained response rate to entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs and obtained anti-virus effect after 1 year treatment.
The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis).
Time frame: 15 months
Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs in a short term.
The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis).
Time frame: 3 months
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entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months