Completed
PHASE4
INTERVENTIONAL
NCT01938820
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
entecavir
Type:
DRUG
Description:
anti-viral therapy
Name:
Thymosin-α
Type:
DRUG
Description:
antiviral and antifibrosis therapy
Primary Outcomes
Measure:
Regression of HBV-induced liver cirrhosis
TimeFrame:
1.5 to 2 years
Description:
Liver cirrhosis regression of 1 point by Ishak scoring system
Trial Information
NCT ID
NCT01938820
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Beijing Friendship Hospital
Last Updated
December 15, 2025