Chronic Hepatitis B Clinical Trial
Official title:
Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients-A Randomized, Double-Blinded, Controlled Trial
To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis B patients.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | February 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital, college of medicine, zhejiang university | Hangzhou | Zhejaing |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs | The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis and changes in the histological features of liver biopsy(steatosis degree, inflammation and fibrosis). | 12 months | No |
Secondary | Differences in the sustained response rate to entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs and obtained anti-virus effect after 1 year treatment. | The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis). | 15 months | No |
Secondary | Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs in a short term. | The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis). | 3 months | No |
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