chronic hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patient with chronic hepatitis B treated with entecavir for more than 6 months. Just before the trial, HBV DNA less than 2.1 log copies/mL, HBs antigen positive, HBe antigen negative, ALT 30 IU/L or less, platelet count 150,000/µL or more Non-cirrhosis Without hepatocellular carcinoma
Exclusion criteria
Exclusion criteria: 1,allergy with entecavir, interferon or vaccination 2,interferon treatment before 6 months of the trial 3,pregnancy or lactation period 4,severe heart disease, chronic renal failure, depression, severe psychotic disease, liver cirrhosis, brain hemorrhage or infarction, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, HCV infection, autoimmune disease 5,treated with shosaiko-to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maintenance of ALT | — |
Secondary
| Measure | Time frame |
|---|---|
| HBe antigen, anti-HBe HBV DNA less than 4 log copies/mL | — |
Countries
Japan