Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of liver cirrhosis due to HBV. The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
Guangxi Ruikang Hospital
Nanning, Guangxi, China
RECRUITINGThe Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
RECRUITINGThe Fifth People's Hospital of Anyang
Anyang, Henan, China
RECRUITINGJingmen No.1 People's Hospital
Jingmen, Hubei, China
RECRUITINGHubei Hospital of TCM
Wuhan, Hubei, China
RECRUITINGTongji Hospital
Wuhan, Hubei, China
RECRUITINGThe First Affiliated Hospital of Hunan University of TCM
Changsha, Hunan, China
RECRUITINGHuai'an No. 4 People's Hospital
Huai'an, Jiangsu, China
RECRUITINGThe Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
RECRUITINGThe Ninth Hospital of Nanchang
Nanchang, Jiangxi, China
RECRUITING...and 10 more locations
Degree of liver fibrosis
The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.
Time frame: 48 weeks
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