Efficacy study of sequential therapy of Peginterferon alfa-2a (Pegasys(TM)) following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with chronic hepatitis B
Not Applicable
Recruiting
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0000042
- Lead Sponsor
- Hanyang University Guri Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 228
Inclusion Criteria
Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml, anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.
Exclusion Criteria
Patient infected concurrently with HCV, HDV and HIV
or patient with a history of antiviral treatment for Hepatitis B
or patient with hepatic decompensation.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HBeAg seroconversion
- Secondary Outcome Measures
Name Time Method the change of HBsAg titer;the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml;The rate of serum HBV DNA < 300 copie;The rate of ALT normalization;The rate of HBsAg loss