UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000589 |
|---|---|
| Receipt number | 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 22:18:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kuwanam@z5.keio.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
