Completed
PHASE4
INTERVENTIONAL
NCT01943617
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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;
Interventions
Name:
Entecavir
Type:
DRUG
Description:
anti-viral therapy
Name:
Thymosin-α
Type:
DRUG
Description:
anti-viral and antitherapy
Primary Outcomes
Measure:
Decompensated rate of Liver Cirrhosis after 2 years treatment
TimeFrame:
2 years
Description:
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.
Trial Information
NCT ID
NCT01943617
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Beijing Friendship Hospital
Last Updated
December 15, 2025