chronic active hepatitis B
Conditions
Interventions
PEG-IFN-alpha 180mcg given by subcutaneous injection once a week for 48 weeks. In the first 4 weeks, Entecavir 0.5mg also given orally once daily.
Sponsors
Department of Hepatology, Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with chronic active hepatitis B who have been treated with Entecavir for 36-72 weeks
Exclusion criteria
Exclusion criteria: 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/microL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| negative HBeAg, undetectable HBV DNA, and normal ALT at 6 months after the end of treatment | — |
Countries
Japan
Contacts
Public ContactMasaru Enomoto
Osaka City University Graduate School of Medicine Department of Hepatology
Outcome results
None listed