Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar
to metavir F2/F3, Ishak 2/3/4) 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
pegylated interferon (peg-IFN) 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, thyroid function, liver ultrasonography, and Fibroscan.
The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5
years after initial therapy.
Phase:
Phase 4
Details
Lead Sponsor:
Beijing Friendship Hospital
Collaborators:
Beijing 302 Hospital Beijing Ditan Hospital Beijing Tiantan Hospital Beijing YouAn Hospital Fifth Hospital of Shijiazhuang City Huashan Hospital Logistics University of Chinese People's Armed Police Forces Nanfang Hospital of Southern Medical University Peking Union Medical College Hospital Peking University Peking University First Hospital Peking University People's Hospital RenJi Hospital Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Public Health Clinical Center Shanghai Zhongshan Hospital Sir Run Run Shaw Hospital Tang-Du Hospital The Affiliated Hospital of Yanbian University The First Affiliated Hospital of Shanxi Medical University Tongji Hospital