UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015105
Receipt number R000017582
Scientific Title A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.
Date of disclosure of the study information 2014/09/10
Last modified on 2019/04/08 12:59:59

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Basic information

Public title

A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.

Acronym

A randomized phase 2 trial of AT-III products in infectious DIC.

Scientific Title

A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.

Scientific Title:Acronym

A randomized phase 2 trial of AT-III products in infectious DIC.

Region

Japan


Condition

Condition

advanced hepatobiliary and pancreatic cancer patients

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A randomized phase 2 trial was conducted in order to investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

AT-III activity after 72 hours

Key secondary outcomes

1) DIC score after 72 hours
2) DIC score after 7 days
3) SIRS score after 72 hours
4) pyrexia rate at the time of 24 hours and 72 hours later


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

500 IU of AT-III, 60 min. intravenous infusion, 3 times every 8 hours

Interventions/Control_2

1,500 IU of AT-III, 60 min. intravenous infusion in a day

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

1) advanced hepatobiliary and pancreatic cancer patients
2) acute DIC
3) AT-III activity less than 70%
4) PS 0-2 adults with informed concent with cocuments

Key exclusion criteria

pregnat or possible pregnat women

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Email

ioka-ta@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Homepage URL


Email

ioka-ta@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology

Institute

Department

Personal name



Funding Source

Organization

Osaka foundation for the prevention of cancer and cardiovascular diseases data center

Organization

Division

Category of Funding Organization

Non profit foundation

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 09 Month 10 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 01 Month 01 Day

Date of IRB

2007 Year 03 Month 01 Day

Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 10 Day

Last modified on

2019 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name