Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir

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 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.

Conditions

• Liver Cirrhosis Due to Hepatitis B Virus

Interventions

DRUG

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 + 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Guangxi Ruikang Hospital

  collaborator OTHER

• Hubei Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Huai'an No. 4 People's Hospital

  collaborator UNKNOWN

• Ruijin Hospital

  collaborator OTHER

• Shenzhen Third People's Hospital

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Wenzhou Central Hospital

  collaborator OTHER

• Jingmen No.1 People's Hospital

  collaborator OTHER

• Affiliated Hospital of Shandong Univercity of TCM

  collaborator UNKNOWN

• The Ninth Hospital of Nanchang

  collaborator OTHER

• The People's Hospital of Ningxia

  collaborator OTHER

• Fifth Hospital of Shijiazhuang City

  collaborator OTHER

• The Fifth People's Hospital of Suzhou

  collaborator OTHER

• The Fifth People's Hospital of Anyang

  collaborator UNKNOWN

• ShuGuang Hospital

  lead OTHER

Principal Investigators

• Chenghai Liu, PhD · ShuGuang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• China

Study Locations