Chronic hepatitis B
Conditions
Sponsors
University of Tokyo Department of Gastroenterology, Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study is designed to enroll patients with HBsAg positive. Other eligibility criteria includes: Eastern Chemotherapy Oncology Group(ECOG)performance status of 0-2, elevated ALT level (more than 1.0 times the upper limit of normal), HBV DNA positive by PCR method, and no prior therapy of nucleoside analogues. Written informed consent is required from all patients.
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows: a previous history of a severe drug hypersensitivity against nucleoside analogues, malignancy within 5 years, severe renal disease (BUN more than 40 mg/dl or creatinine more than 2.0 mg/dl) the presence of other forms of liver disease such as auto immune hepatitis, coinfection with hepatitis C, history of liver transplantation, participation in another clinical trial, receiving prohibition medication for combination, and doctors' stop not to register to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| an incidence of resistant hepatitis B virus to both LAM and ADV, or ETV at 2 and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| normalization of the alanine aminotransferase level a reduction in the serum HBV DNA level HBeAg loss and seroconversion an incidence of hepatocellular carcinoma five-year survival | — |
Countries
Japan
Contacts
Public ContactTadashi Goto
University of Tokyo Department of Gastroenterology, Faculty of Medicine
Outcome results
None listed