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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name