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Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial

Not Applicable
Recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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