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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015132
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email ckubota@staff.kanazawa-u.ac.jp

Sponsor
Institute Div. Hematology and Div. Transfusion Medicine, Kanazawa University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017573


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