NCT01943617

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Entecavir	anti-viral therapy
DRUG	Thymosin-α	anti-viral and antitherapy

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-09-17
• Last updated: 2018-07-27

Locations

21 sites across 1 country: China