Chronic hepatitis B
Conditions
Interventions
entecavir 0.5mg/day
no treatment
Sponsors
Hiroshima university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic hepatitis B patients who had never been treated with any nucleot(s)ide analogues 2. Patients whose HBV DNA levels were less than 5 Log copies/ml at the baseline 3. Patients whose ALT levels were more than 31 U/L 4. Age: more than 20 y.o., Gender: unmentioned 5. Patients who can give written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Patients who have hypersensitivity to entecavir 2. Patients who have a renal dysfunction (eGFR<50mL/min/1.73m2) or who need hemodialysis due to chronic renal failure 3. Patients who have malignacies 4. Patients who were infected with both hepatitis B virus and the other viruses, such as human immunodeficiency virus or hepatitis C virus 5. Pregnant or lactating women or women who may be pregnant 6. Female patients who want pregnancy, Male patients who may be pregnant by pregnant women 7. Patients who was judged unreasonable to carry out this study by the research doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hepatocellular carcinoma, Progression of liver fibrosis, Reduction of serum markers (HBsAG, HBcrAg, M2BPGi), Safety | — |
Countries
Japan
Contacts
Public ContactMasataka Tsuge
Hiroshima university hospital Department of Gastroenterology and Metabolism
Outcome results
None listed