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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
