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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000589
Receipt No. R000000715
Scientific Title Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis
Date of disclosure of the study information 2007/02/14
Last modified on 2018/03/12

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Basic information
Public title Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis
Acronym Open-label trial of G-CSF on systemic sclerosis-related peripheral vascular disease
Scientific Title Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis
Scientific Title:Acronym Open-label trial of G-CSF on systemic sclerosis-related peripheral vascular disease
Region
Japan

Condition
Condition systemic sclerosis (SSc)
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of G-CSF on SSc-related peripheral vascular disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Digital ulcers at the 24 weeks
Key secondary outcomes The number of circulating endothelial precursors in the peripheral blood,
Raynaud's core set, safety

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 Granulocyte-colony stimulating factor (G-CSF), "Gran"
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with digital ulcers resistant to conventional therapies including prostanoids

Written informed consent must be obtained.
Key exclusion criteria Medical history of allergic reactions to G-CSF derivation or other recombinant proteins produced in E.coli

Patient diagnosed as having myeloid leukemia, myelodysplastic syndrome and other hematopoietic malignancies

Patient with severe liver, renal, and/or cardio-respiratory dysfunctions

Patient with severe splenomegaly

Patient with thrombopenia ( <100,000 / microliter)

Medical history of thromboembolism ( cerebrovascular disease, ishemic heart disease, deep vein thrombosis, pulmonary thromboembolism )
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Kuwana
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email kuwanam@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Kuwana
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email kuwanam@z5.keio.jp

Sponsor
Institute Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2007 Year 02 Month 14 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
2006 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2013 Year 02 Month 01 Day
Date of closure to data entry
2013 Year 02 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 01 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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