UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007553 |
|---|---|
| Receipt number | R000008922 |
| Scientific Title | Pharamocokinetics study of recombinant thrombomodulin in pediatric patients with hematological disease |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/11/20 17:31:35 |
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Basic information
Public title
Pharamocokinetics study of recombinant thrombomodulin in pediatric patients with hematological disease
Acronym
PK study of recombinant thrombomodulin in pediatric patients
Scientific Title
Pharamocokinetics study of recombinant thrombomodulin in pediatric patients with hematological disease
Scientific Title:Acronym
PK study of recombinant thrombomodulin in pediatric patients
Region
| Japan |
Condition
Condition
pediatric patients with hematological disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study pharmacokinetics of recombinant thrombomodulin in pediatric patients
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
pharmacokinetics of recombinant thrombomodulin
Key secondary outcomes
recovery rate from disseminated intravascular coagulation, change in laboratory data including coagulation tests before and after administration of recombinant thrombomodulin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
blood sampling
Interventions/Control_2
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with hematological and oncological disease who suffer from disseminated intravascular coagulation.
Key exclusion criteria
1. Patients who are contraindicated from being used Recomodulin
2. severe renal insufficiency
3. Patients who are excluded from the study by physicians' decision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goto, Hiroaki |
Organization
Kanagawa Children's medical center
Division name
hematology/reproduction medicine
Zip code
Address
2-138-4 Mutsukawa Minami-ku, Yokohama
TEL
045-711-2351
hgotou@kcmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goto, Hiroaki |
Organization
Kanagawa Children's medical center
Division name
hematology/reproduction medicine
Zip code
Address
2-138-4 Mutsukawa Minami-ku, Yokohama
TEL
045-711-2351
Homepage URL
hgotou@kcmc.jp
Sponsor or person
Institute
Yokohama City University School of Medicine, Dept. of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Children's medical center
Organization
Division
Category of Funding Organization
Other
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
横浜市立大学附属病院（神奈川県）、神奈川県立こども医療センター（神奈川県）、済生会横浜市南部病院（神奈川県）、昭和大学藤が丘病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 22 | Day |
Last modified on
| 2015 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008922
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
