Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-UMIN000011666
- Lead Sponsor
- Toranomon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Prior exposure of interferon, antiviral agents, antitumoral agents, immunosupressive drugs, and radiotherapy within 6 months 2. HCV RNA positivity 3. Complicating other liver disease 4. The diagnosis of Liver cirrhosis, hepatic failure, and liver cancer 5. The history of hepatic encephalopathy, varices bleeding, and ascites 6. Complicating collagen disease 7. The history of interstitial pneumonia 8. Severe heart disease 9. The history of epilepsy 10. The history of depression 11. The history of abnormal thyroid function 12. The history of stroke 13. Severe diabetes 14. The history of malignant tumor within 5 years 15. The history of liver, kidney or bone marrow transplantation 16. Retinopathy 17. blood test abnormality as follows: (a) neutrophil < 1,500 /mm3 (b) platelets count < 90,000/ mm3 (c) Hb < 10 g/dL (d) prothrombin time > 20s or < 60% (e) ALT > 10 times ULN (f) total bilirubin > 2.0 mg/dL (g) albmin < 3.2 g/dL (h) creatinine clearance < 50 mL/min 18. Pregnancy 19. Doctors condider inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method