Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-UMIN000007231
- Lead Sponsor
- Division of Gastroenterology, Department of Internal Medicine,Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
1. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir 2. Severe state of liver damage (the patient who conflicts with two items or more,total bilirubin is more than 2.0 mg/dl, prothrombin time is less than 70 %, and albumin is less than 3.6 g/dl) 3. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4. Severe state of complication, especially, patients were not eligible if they kept the function of bone marrow, kidney, heart, or respiration 5. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 6. Patient who is administering the sho-sai-ko-to 7. A patient with the previous history of interstitial pneumonia 8. Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other IFNs 9. Patient who has previous history of hypersensitivity for biological products such as vaccines 10. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history 11. Additionally, patient judged by doctor that participation in this study is improper
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [HBeAg-positive chronic hepatitis B] This study had two predetermined primary measures of efficacy assessed after 24 weeks of follow up for 1) HBe seroconversion 2) the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 5.0Log copies/ml [HBeAg-negative chronic hepatitis B] the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 4.0Log copies/ml after 24 weeks of follow up
- Secondary Outcome Measures
Name Time Method