NCT01148576

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

Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients-A Randomized, Double-Blinded, Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Chronic hepatitis B (CHB) affects approximately 360 million persons worldwide and is the most common cause of liver disease and affects over 10% of the general population in China. Hepatic steatosis is the main hepatic presentation of non- alcoholic fatty liver disease that is becoming another important liver disorder both in China and worldwide with economic development. It would be expected that hepatic steatosis might occur in CHB patients and recent studies show the frequency of steatosis in CHB ranges from 27% to 51%. However, the effect of steatosis on the anti-viral treatment in CHB patients is still vague. The aim of this RCT is to investigate the effect of steatosis on the therapeutic effect of entecavir in chronic hepatitis B patients. We will compare the anti-viral effect of entecavir among four groups: CHB group with entecavir therapy, CHB + steatosis group with entecavir therapy, CHB + steatosis group with entecavir + essentiale therapy and CHB + steatosis group with entecavir + vitamin E therapy. The speculated points are set as 3 months, 12 months and 15 months. Liver biopsy will be carried out at beginning and the 12th month. Other serum biochemical and viral markers are recorded as well as CT or ultrasound scan are repeated.

Conditions

• Chronic Hepatitis B
• Hepatic Steatosis

Interventions

Type	Name	Description
DRUG	entecavir	entecavir 0.5 mg qd for 12 months
DRUG	entecavir	entecavir 0.5 mg qd for 12 months
DRUG	essentiale + entecavir	entecavir 0.5 mg qd for 12 months，Essentiale 2 tablets tid in the first 3 months and 1 tablets tid in the rest 9 months
DRUG	Vitamin E + entecavir	entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2010-06-22
• Last updated: 2010-06-22

Locations

1 site across 1 country: China