Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Summary

Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.

Conditions

• Liver Cirrhosis

Interventions

DRUG

entecavir

anti-viral therapy

DRUG

Thymosin-α

antiviral and antifibrosis therapy

Sponsors & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Peking University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Fudan University

  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