Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
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.
Liver Cirrhosis Due to Hepatitis B Virus
Drug: Entecavir + Fuzheng Huayu Tablet
Drug: Entecavir + Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Degree of liver fibrosis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]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 reversion.
|Study Start Date:||September 2014|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
|Drug: Entecavir + Placebo|
Experimental: Entecavir + Fuzheng Huayu Tablet
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
|Drug: Entecavir + Fuzheng Huayu Tablet|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02241590
|Contact: Chenghai Liu, PhDfirstname.lastname@example.org|
|Hubei Provincial Hospital of TCM||Not yet recruiting|
|Wuhan, Hubei, China|
|The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine||Not yet recruiting|
|Changsha, Hunan, China|
|Huai'an No. 4 People's Hospital||Not yet recruiting|
|Huai'an, Jiangsu, China|
|Beijing Ditan Hospital Capital Medical University||Not yet recruiting|
|Beijing Youan Hospital Capital Medical University||Not yet recruiting|
|Ruikang Hospital of Guangxi Traditional Chinese Medical University||Not yet recruiting|
|Ruijin Hospital||Not yet recruiting|
|Shanghai, China, 201203|
|Contact: Zhimin Zhao, PhD +8615800581663 email@example.com|
|Zhongshan Hospital Fudan University||Not yet recruiting|
|Shenzhen Third People's Hospital||Not yet recruiting|
|Study Director:||Chenghai Liu, PhD||ShuGuang Hospital|