UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001815 |
|---|---|
| Receipt number | R000001929 |
| Scientific Title | Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy |
| Date of disclosure of the study information | 2009/03/30 |
| Last modified on | 2010/04/01 15:13:51 |
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Basic information
Public title
Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy
Acronym
Preventive effect of menatetrenone against recurrence of hepatocellular carcinoma
Scientific Title
Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy
Scientific Title:Acronym
Preventive effect of menatetrenone against recurrence of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess whether menatetrenone suppresses the recurrence of hepatocellular carcinoma in patients undergo surgical resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease-free survival period after hepatectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The study was designed to test the hypothesis that MNT would reduce the incidence of recurrence of HCC in patients underwent initial hepatectomy.
The patients stated to take 15 mg of menatetrenone, 3 times a day, orally everyday.
Interventions/Control_2
Control group does not take any drugs.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergo curative hepatectomy at the Second Department of Surgery, Dokkyo Medical University.
Key exclusion criteria
Patients who take warfarin or other vitamin K analogs.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Kubota |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
Kitakobayashi 880, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokihiko Sawada |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
Kitakobayashi 880, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
Homepage URL
tsawada@dokkyomed.ac.jp
Sponsor or person
Institute
Second Department of Surgery
Dokkyo Medical University
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
| 2009 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | 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
| 2009 | Year | 03 | Month | 30 | Day |
Last modified on
| 2010 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001929
