Nucleoside analogue experienced patients infected with hepatitis B virus infection
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients were eligible if they met the following inclusion criteria: (i) infected with HBV alone, (ii) age =>20 years, (iii) diagnosed as chronic hepatitis B, (iv) WBC =>3000/mm3 , (v) neutrophils =>1500/mm3, (vi) platelets =>90000/mm3, (vii) hemoglobin => 12 g/dL, (viii) Doctors judged patient as appropriate person in this trial , (ix) patients experienced with NA, (x)HBV DNA levels < 3 log IU/mL, (xi) no or mild hepatic fibrosis, (xii) patient and his/her family underst and well this disease and treatment.
Exclusion criteria
Exclusion criteria: 1) Pregnancy 2) Severe liver diseases 3) Cirrhosis or hepatic failure such as chronic liver diseases, e.g. autoimmune hepatitis and alcoholic hepatitis 4) Severe other diseases 5) History of pneumonitis 6) Past-history of hypersensitivity against interferon or peginterferon, etc. 7) Severe mental disorders 8) Abnormal hematological exams 9) Past-history of hypersensitivity against vaccination, etc. 10) Under treatment of TJ-9 11) Doctor judged patient as inappropriate person in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA and ALT levels at 24 week after stopping the treatment | — |
Countries
Japan
Contacts
Chiba University, Graduate School of Medicine Department of Gastroenterology and Nephrology