Optimized Treatment and Regression of HBV-induced Early Cirrhosis

NCT01938820 Phase 4 COMPLETED

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.

Details

Lead sponsor	Beijing Friendship Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	82
Start date	2013-06
Completion	2016-12

Conditions

• Liver Cirrhosis

Interventions

• entecavir
• Thymosin-α

Primary outcomes

• Regression of HBV-induced liver cirrhosis — 1.5 to 2 years
  Liver cirrhosis regression of 1 point by Ishak scoring system

Countries

China