chronic hepatitis B, HBV
Conditions
Interventions
Eligible patients receive pegylated interferon 180 mcg/m2 body surface area weekly for 24 or 48 weeks. In addition, patients intake entecavir 0.01mg/kg/day for the first 12 weeks. Patients are followe
Sponsors
Tajiri Hitoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient age is greater than 3 years of age and less than 18 years of age at the time of obtaining informed consent. 2. sustained elevation in ALT (greater than 60 IU/l) for more than six months. 3. Patients with HBeAg positive or negative. 4. HBVDNA titer greater than 4.0 log copies /ml 5. Fibrosis stage F2-3 or Hepatitis activity grade A2-3 according to the New Inuyama classification. 6. Written informed consent after adequate explanation and acceptance.
Exclusion criteria
Exclusion criteria: 1. Patients with a suspicion of liver cirrhosis by blood examination or imaging studies. 2. Patients who is diagnosed as liver cirrhosis by pathological examination. 3. Patients with hepatocellular carcinoma. 4. Patients with poor adherence of medicine. 5. Patients who have any underlying disorders which can be affected by the treatment. 6. Patients who are assessed to be ineligible for this study by the principle investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. ALT normalization 2. Seroconversion in HBeAg and HBeAb system 3. Decrease in HBV DNA titers lower than 4 log copies/ml 4. Decrease in HBsAg titers lower than 1000 IU/ml | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)any side effects and their frequency, (2)effect on growth rate | — |
Contacts
Public ContactHitoshi Tajiri
Osaka General Medical Center
Outcome results
None listed