Status:
UNKNOWN
Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients
Lead Sponsor:
Zhejiang University
Conditions:
Chronic Hepatitis B
Hepatic Steatosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 i...
Eligibility Criteria
Inclusion
- Patients should be diagnosed with chronic hepatitis B infection and hepatic steatosis
- CHB infection
- HBV-DNA ≥ 1×105 copies/ml；
- HBeAg positive ；
- ALT between the 2-10 times of the upper limit level
- 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
- those receiving antiviral treatment before the study
- those on hepatoxic drug treatment,
- those consuming alcohol regularly or excessively,
- those diagnosed of cirrhosis, anti-HCV or anti-Delta positive patients,
- those diagnosed as having autoimmune or other metabolic liver diseases
- those have wilson's disease, PBC, PSC, IBD and other diseases that may influence the process and effect of therapy
- those who are pregnant, have mental disorder and were received anti-viral treatment
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01148576
Start Date
June 1 2010
End Date
February 1 2012
Last Update
June 22 2010
Active Locations (1)
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1
The first affiliated hospital, college of medicine, zhejiang university
Hangzhou, Zhejaing, China, 310003