HBV related CHB/LC/HCC
Conditions
Interventions
Entecavir 0.5mg/day
Sponsors
Tokyo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age at the time of the agreement acquisition 20 years old or older 2) No macroscopic vascular invasion, No extra hepatic lesion, be resected a hepatocellular carcinoma for a radical cure purpose. (no clear persistence. There is more than 2 years after treatment in the case of a 3) HBs antigen is positive, and given a diagnosis of hepatitis B, cirrhosis of the liver at the time of screening clinically (before resection). 4)WBC more than 2,000/mm3, Hb more than 7.5g/dL, Platelet more than 50,000 / mm3 . 5)The patients with liver disease to meet all the following conditions:-The extension that is with three seconds of the normal value or less of prothrombin time, or INR is 1.5 or less. -Albumin is more than 2.5g/dL. -Total bilirubin is less than2.5g/dL. 6)There were not the severe complications just after the operation, and attending staff judged to be able to leave the hospital recurrence
Exclusion criteria
Exclusion criteria: (1)the pregnancy and the nursing. (2)Women with childbearing age who is impossible to undergo appropriate contraception. (3) The women who are positive by an examination of pregnancy with less than 72 hours before administration start or at screening. (4)The patients with bleeding varicose vein, the hepatic encephalopathy now, and need treatment. (5) The patients with other liver diseases by an anamnesis, liver biopsy or a laboratory study. (6) CP score 13 or more in the patients with cirrhosis. (7) Absolute non-curative resection case. (8) Recurrent case within 24 months after the HCC radical operation. (9) HIV infection (10)Pancreatitis within 24 weeks before study drug administration start. (11)The patients who were judged when alcoholism did not enable appropriate medication or raised the risk of hepatotoxicity and the pancreatitis. (12)The patients with difficulty in conducting a clinical trial by other serious conditions. (13)Serum creatinine levels exceed the twice the normal value upper limit, or eGFR<30mL/min or less. (14) Hemoglobin < 7.5 g/dL. (15) Platelet count < 50,000/mm3. (16) A granulocyte count < 1,500/ mm3. (17) The patients with allergic history by the nucleoside analog. (18)The patients who received immunosuppressive therapy within four weeks before therapeutic drug administration start. (19)The patients who received the IFN within 12 weeks before study. (20) The patients using ETV before. (21) The patients received the hepatitis B therapeutic drug (lamivudine) of the nucleoside analog. (22) The case that we continued surgery until just before that more than three months, and was given nucleic acid analog. (23) The patients who cannot be given it orally. (24) The patients who have difficulty in puncture of peripheral vessels. (25) The patients who are restricted forcibly by a legal reason or a mental disease, a physical disease (including the infection). (26) In addition, the patients that attending staff of this study judged that administration was inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| effective evaluation (1) Overall survival (2) HBV-DNA at1m,3m,6m,9m,12m (3) Liver function (4) Child Pugh Score Safety assessment (1) Adverse event frequencies (2) Liver function 6m,12m later after registration (3) Liver residual function(ICGR-15) (4) Child-Pugh score (5) Background liver histology at the re-resection | — |
Countries
Japan
Contacts
Public ContactYosuke Inoue
Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division
Outcome results
None listed