Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

• Status: Unknown status
• Trial end date: 2019-06-01

Summary

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.

• Phase: Phase 4

Details

• Lead Sponsor: ShuGuang Hospital
• Collaborators: Affiliated Hospital of Shandong Univercity of TCM; Beijing Ditan Hospital; Beijing YouAn Hospital; China-Japan Friendship Hospital; Fifth Hospital of Shijiazhuang City; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Guangxi Ruikang Hospital; Huai'an No. 4 People's Hospital; Hubei Hospital of Traditional Chinese Medicine; Jingmen No.1 People's Hospital; Jingmen No.1 People’s Hospital; Ruijin Hospital; Shandong University of Traditional Chinese Medicine; Shanghai Zhongshan Hospital; Shenzhen Third People's Hospital; The Fifth People's Hospital of Anyang; The Fifth People's Hospital of Suzhou; The Fifth People’s Hospital of Anyang; The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine; The Ninth Hospital of Nanchang; The People's Hospital of Ningxia; Tongji Hospital; Wenzhou Central Hospital
• Treatments: Entecavir