UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000431 |
|---|---|
| Receipt number | R000000524 |
| Scientific Title | The effectiveness of a Vitamin K2 analog on the recurrence of HCC after curative therapy |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2011/06/20 21:34:09 |
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Basic information
Public title
The effectiveness of a Vitamin K2 analog on the recurrence of HCC after curative therapy
Acronym
Vitamin K2 therapy and HCC recurrence after curative therapy
Scientific Title
The effectiveness of a Vitamin K2 analog on the recurrence of HCC after curative therapy
Scientific Title:Acronym
Vitamin K2 therapy and HCC recurrence after curative therapy
Region
| Japan |
Condition
Condition
patients with HCC after curative treatment
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether Vitamin K2 analog administration reduces HCC recurrance rate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cumulative tumor recurrence rate
Key secondary outcomes
survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of Vitamin K2 analog
Interventions/Control_2
without administration of Vitamin K2 analog
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a)above 20 years and under 80 years
b)Patients underwent curative treatment of HCC
Key exclusion criteria
(a)A planned case of postoperative interferon therapy after curative treatment of HCC
(b) other malignancies
(c)Vitamin K allergy
(d)receiving warfarin or aspirin
(e)ruptured HCC
(d)Operation-related death
(e)HCC reccurence detected via CT within 3 or 4 weeks
(f)judged to be inadequate case of this clinical test for other reasons by doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Internal Medicine
Zip code
Address
2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi, Japan
TEL
0827-31-7121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Internal Medicine
Zip code
Address
2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi, Japan
TEL
0827-32-7121
Homepage URL
takuma@enjoy.ne.jp
Sponsor or person
Institute
National Hospital Organization Iwakuni Clinical Center
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
| 2014 | Year | 01 | Month | 20 | 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
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | 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
| 2006 | Year | 06 | Month | 20 | Day |
Last modified on
| 2011 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000524
