NCT01938781

Optimized Treatment and Regression of HBV-induced Liver Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Fibrosis

Interventions

Type	Name	Description
DRUG	entecavir	antiviral therapy
DRUG	Peg-IFN	antiviral and antifibrosis therapy

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-09-10
• Last updated: 2018-07-27

Locations

21 sites across 1 country: China