UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009276 |
|---|---|
| Receipt number | R000010899 |
| Scientific Title | Study of efficacy of romiplostim for unreactive condition in platelet transfusion after cord blood transplantation |
| Date of disclosure of the study information | 2012/11/07 |
| Last modified on | 2024/08/15 10:24:45 |
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Basic information
Public title
Study of efficacy of romiplostim for unreactive condition in platelet transfusion after cord blood transplantation
Acronym
Cord blood transplantation and romiplostim
Scientific Title
Study of efficacy of romiplostim for unreactive condition in platelet transfusion after cord blood transplantation
Scientific Title:Acronym
Cord blood transplantation and romiplostim
Region
| Japan |
Condition
Condition
cord blood transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study of efficacy of romiplostim PC-unreactive condition after CBT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy of romiplostim
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CBT
Key exclusion criteria
severe infection
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
10-15, Fumizono-cho, Moriguchi
TEL
06-6993-9453
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
nomurash@hirakata.kmu.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
KIrinn -Kyouwa
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 07 | 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
| 2012 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 05 | 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
| 2012 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010899
