Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis B patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: alpha-Tocopherol; Entecavir; Essential 303 forte; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

Patients should be diagnosed with chronic hepatitis B infection and hepatic steatosis

1. CHB infection

• HBV-DNA ≥ 1×105 copies/ml；

• HBeAg positive ；

• ALT between the 2-10 times of the upper limit level

2. hepatic steatosis According to the "Guidelines for the assessment and management of non-alcoholic fatty liver disease in the Asia-Pacific region: executive summary", with test of CT scan or B ultrasound and confirmation of liver biopsy(in portion of patients)

Exclusion Criteria:

1. those receiving antiviral treatment before the study

2. those on hepatoxic drug treatment,

3. those consuming alcohol regularly or excessively,

4. those diagnosed of cirrhosis, anti-HCV or anti-Delta positive patients,

5. those diagnosed as having autoimmune or other metabolic liver diseases

6. those have wilson's disease, PBC, PSC, IBD and other diseases that may influence the process and effect of therapy

7. those who are pregnant, have mental disorder and were received anti-viral treatment