UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015132 |
|---|---|
| Receipt number | R000017573 |
| Scientific Title | Safety and Efficacy of G-CSF 'filgrastim BS' administration in the peripheral blood stem cell (PBSC) mobilization |
| Date of disclosure of the study information | 2014/09/11 |
| Last modified on | 2018/09/14 17:38:22 |
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Basic information
Public title
Safety and Efficacy of G-CSF 'filgrastim BS' administration in the peripheral blood stem cell (PBSC) mobilization
Acronym
Safety and Efficacy of filgrastim BS in the PBSC mobilization
Scientific Title
Safety and Efficacy of G-CSF 'filgrastim BS' administration in the peripheral blood stem cell (PBSC) mobilization
Scientific Title:Acronym
Safety and Efficacy of filgrastim BS in the PBSC mobilization
Region
| Japan |
Condition
Condition
Related donors for allogeneic PBSC transplantation
Classification by specialty
| Hematology and clinical oncology | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the safety and efficacy of the G-CSF 'filgrastim BS' administration in the PBSC mobilization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Adverse events during the PBSC mobilization
2. Efficacy of the PBSC mobilization
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
Subcutaneous administration of filgrastim BS 300mcg twice daily on days 1-4 and one dose on day 5.
Complete blood count is carried out on days 1-5.
PBSCs are harvested on days 4 and 5.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Give informed consent for the PBSC mobilization by G-CSF administration.
2. Enroll in the accident insurance for the PBSC mobilization.
3. Give informed consent for the current study, approved by the institutional ethics comittee.
Key exclusion criteria
In case the attending physician judge the candidate not suitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAKAO, Shinji |
Organization
Kanazawa University Hospital
Division name
Hematology
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-265-2274
snakao8205@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KUBOTA, Chizuru |
Organization
Kanazawa University Hospital
Division name
Hematology
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-265-2275
Homepage URL
ckubota@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Div. Hematology and Div. Transfusion Medicine, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fuji Pharma Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
YES
Study ID_1
2013-038
Org. issuing International ID_1
Innovative Clinical Research Center, Kanazawa University Hospital
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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 26 | Day |
Last follow-up date
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 | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017573
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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