UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma derived from HBV infection: a prospective trial
Title of the study (Brief title)	ETV-HCC
Region	Japan

Condition
Condition	HBV related CHB/LC/HCC
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine it in a prospective study whether nucleoside analog administration can be provided safely and decrease a recurrence after the curative resection of hepatocellular carcinoma with the chronic hepatitis B and cirrhosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence free survival
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Entecavir 0.5mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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.
Target sample size	40

Research contact person
Name of lead principal investigator	Norihiro Kokudo
Organization	Tokyo University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Email	sukeyaubj@yahoo.co.jp

Public contact
Name of contact person	Yosuke Inoue
Organization	Tokyo University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Homepage URL
Email	sukeyaubj@yahoo.co.jp

Sponsor
Institute	Tokyo University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 10 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 18 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007090