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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name