Chronic hepatitis B
Conditions
Interventions
Administration of Entecavir for at least 24 weeks since the beginning of treatment At 20 weeks, HBV-DNA titer below 4log, then switch to PEG-IFN-alfa2a At 20 weeks, HBV-DNA titer more than 4log, En
Sponsors
Division of Gastroenterology and Hepatology, Department of Internal Medicine, St. Marianna University School of Medicine,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age below 40 years old 2. Patient with chronic hepatitis B, untreated with IFN or nuclear analogue Non-cirrhosis 3. Genotype C, HBe Antigen positive, HBV-DNA over 7log copies, ALT over 100IU/L Just before the trial, Neutrophil more than 1,500/ul, Platelet more than 90,000/ul, hemoglobin more than 10g/dl 4. ECOG performance status 0 or 1 5. Obtained an informed consent from all study participants
Exclusion criteria
Exclusion criteria: 1. HCV antibody positive 2. Liver cirrhosis 3. Pregnancy or lactation period 4. Entecavir or interferon therapy before the study 5. Treated with shou-saikotou (Kampo medicine) 6. Past history of interstitial pneumoniae 7. Past history of autoimmune hepatitis 8. Allergy with vaccination 9. Severe mentally disordered, severe psychotic disease 10. Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of HBV-DNA titer, below 4 log copies/mL after 48 weeks of preceding administration of Entecavir with PEG-IFN-alfa2a | — |
Countries
Japan
Contacts
Public ContactHiroki Ikeda
St. Marianna University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed