Hepatitis B Virus Related Cirrhosis Clinical Trial
Official title:
A Multi-Center Study to Assess the Efficacy and Safety of Traditional Chinese Medicine Combined With Entecavir for Patients With Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV
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 regress or reverse liver fibrosis in patients with chronic Hepatitis and
liver cirrhosis due to HBV, however some patients keep existence or development although HBV
DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the
anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix,
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 refractory liver fibrosis
in liver cirrhosis due to HBV.
The primary objective of this study is to establish the safety and efficacy of the
combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in
liver cirrhosis due to HBV.
n/a