Chronic hepatitis B
Conditions
Interventions
Entecavir group Entecavir 0.5mg is administered orally once daily with conventional treatment (ursodeoxycholic acid, Stronger Neo-minophagen C (SNMC, a glycyrrhizin preparation), and Shosaiko-to, et
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, curatively treated HCC with RFA, ALT values more than the upper limit of normal(ULN) to 2.5 times the ULN, serum HBV DNA positive (above the cut off value), 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 an ingredients of Entecavir, extrahepatic metastasis lesion of HCC, malignancy except for HCC (double cancer), 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, and doctors' stop not to register to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with 1.improvement of serum alanine aminotransferase, ALB, T.Bil, PT, 2.undetectable HBV DNA as measured by PCR assay, at week 96. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.HCC recurrence rates and the period to HCC recurrence 2.five-year survival rate | — |
Countries
Japan
Contacts
Public ContactTadashi Goto
University of Tokyo Department of Gastroenterology, Faculty of Medicine
Outcome results
None listed