Efficacy and safety of Entecavir/PEG-IFN-alpha sequential therapy for chronic active hepatitis B
- Conditions
- chronic active hepatitis B
- Registration Number
- JPRN-UMIN000006943
- Lead Sponsor
- Department of Hepatology, Osaka City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
1. presence of resistance to nucleoside analog (such as lamivudine and entecavir) 2. decompensated liver disease (total bilirubin >=2.0 mg/dL, prothrombin time <70 %, and albumin <3.6 g/dL) 3. other likely causes of chronic liver disease, such as autoimmune or alcoholic liver disease 4. severe complication (ex. impaired renal, cardiac or respiratory function) 5. women who are possibly pregnant, expectant mothers, and lactating mothers 6. history of interstitial pneumonitis 7. drug allegy to interferon 8. depression or other severe psychosomatic disorders 9. Unacceptable values of complete blood counts as follows: i) WBC counts=<3,000/microL ii) Neutrophil counts=<1,500/microL iii) Hemoglobin concentration=<12g/dL iv) Platelet counts=<90,000/micro
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method