UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001000 |
|---|---|
| Receipt number | R000001080 |
| Scientific Title | Efficacy of entecavir for chronic hepatitis B patients after curative treatment of hepatocellular carcinoma :randomized controlled trial |
| Date of disclosure of the study information | 2008/01/30 |
| Last modified on | 2010/12/15 20:36:29 |
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Basic information
Public title
Efficacy of entecavir for chronic hepatitis B patients after curative treatment of hepatocellular carcinoma :randomized controlled trial
Acronym
ETV for CH-B after HCC treatment
Scientific Title
Efficacy of entecavir for chronic hepatitis B patients after curative treatment of hepatocellular carcinoma :randomized controlled trial
Scientific Title:Acronym
ETV for CH-B after HCC treatment
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of entecavir in patients after treatment for hepatitis B virus (HBV)-related hepatocellular carcinoma with radiofrequency ablation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
1.HCC recurrence rates and the period to HCC recurrence
2.five-year survival rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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, etc)
Interventions/Control_2
non-Entecavir group
conventional treatment only
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
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.
Key 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.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichiro Shiina |
Organization
University of Tokyo
Division name
Department of Gastroenterology, Faculty of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Goto |
Organization
University of Tokyo
Division name
Department of Gastroenterology, Faculty of Medicine
Zip code
Address
TEL
03-3815-5411
Homepage URL
tadagotou-gi@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Department of Gastroenterology, Faculty of Medicine
Institute
Department
Personal name
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
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
| 2008 | Year | 01 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 29 | Day |
Last modified on
| 2010 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001080
