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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005992
Receipt No. R000007090
Scientific Title Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma derived from HBV infection: a prospective trial
Date of disclosure of the study information 2011/07/18
Last modified on 2019/01/22

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Basic information
Public title Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma
derived from HBV infection:
a prospective trial
Acronym ETV-HCC
Scientific Title Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma
derived from HBV infection:
a prospective trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Norihiro Kokudo
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
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
1st name
Middle name
Last name Yosuke Inoue
Organization Tokyo University Hospital
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 05 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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