Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Summary

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;

Conditions

• Liver Cirrhosis

Interventions

DRUG

Entecavir

anti-viral therapy

DRUG

Thymosin-α

anti-viral and antitherapy

Sponsors & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Peking University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Beijing 302 Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Fifth Hospital of Shijiazhuang City

  collaborator OTHER

• Logistics University of Chinese People's Armed Police Forces

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• The Affiliated Hospital of Yanbian University

  collaborator OTHER

• Beijing Friendship Hospital

  lead OTHER

Principal Investigators

• Hong You, Doctor · Beijing Friendship Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• China

Study Locations