Liver Cirrhosis Due to Hepatitis B Virus Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir in Liver Cirrhosis Patients Due to Hepatitis B Virus
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.
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