UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006607 |
|---|---|
| Receipt number | R000007818 |
| Scientific Title | G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2) |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2015/01/08 09:36:51 |
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Basic information
Public title
G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)
Acronym
G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)
Scientific Title
G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)
Scientific Title:Acronym
G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)
Region
| Japan |
Condition
Condition
acute cerebral infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform placebo-controlled trial of G-CSF(150 and 300 micrograms/body/day i.v. for 5 days) in 100 patients with ischemic stroke, in order to its safety and tolerability, and to evaluate the effectiveness of low dose G-CSF on clinical outcomes at 3 months after the onset.
Basic objectives2
Others
Basic objectives -Others
We perform placebo-controlled trial of G-CSF(150 and 300 micrograms/body/day i.v. for 5 days) in 100 patients with ischemic stroke, in order to confirm the optimal dose of G-CSF.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Safety(leukocyte count, size of spleen)
Clinical outcome at 3 months after the onset(mRS, BI)
Key secondary outcomes
Size of infarct on MRI, biomarkers such as inflammation cytokines, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
G-CSF(75 micrograms/body) is intravenously given twice a day for 5 days at 24 hours after onset.
Interventions/Control_2
G-CSF(150 micrograms/body) is intravenously given twice a day for 5 days at 24 hours after onset.
Interventions/Control_3
Saline (50ml) as a placebo is intravenously given twice a day for 5 days at 24 hours after onset.
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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Acute ischemic stroke at 24 hours after onset.
2.Patients with occlusion of middle cerebral artery territory, at least including its cortical branch, on MRI.
3.Atherothrombotic or cardioembolic strokes.
4.NIHSS:4-22 points
5.Age:45-85 years old.
6.Obtain informed consent by the document.
Key exclusion criteria
1.Splenomegaly or splenic lesions on echo.
2.Leukocytosis more than 15000/mm3
3.Past history of G-CSF treatment.
4.Plan for percutaneous angiography or bypass operations.
5.Difficult to perform MRI.
6.Past histries of symptomatic intracranial hemorrhage, bleeding tendency or coagulating disorders.
7.Hyper reactivity to G-CSF.
8.Congestive heart failure or uncontrollable angina.
9.Thrombocytopenia(less than 140000/mm3)
10.Liver dysfunction(AST(GOT),ALT(GPT) more than 100 IU/L)
11.Renal dysfunction (creatinine 1.5mg/dl and more)
12.Difficult to continue this trial due to social problems, etc.
13.Join other clinical trials.
14.Inappropriate to enroll in this trial by the judgment of the doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunya Takizawa |
Organization
Tokai University, School of Medicine.
Division name
Division of Neurology, Department of Internal Medisine.
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
shun@is.icc.u-tokasi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunya Takizawa |
Organization
Tokai University, School of Medicine.
Division name
Division of Neurology, Department of Internal Medicine.
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
shun@is.icc.u-tokasi.ac.jp
Sponsor or person
Institute
Tokai University, School of Medicine, Division of Neurology, Department of Internal Medicine.
Institute
Department
Personal name
Funding Source
Organization
Division of Neurology, Department of Internal Medicine.Tokai University, School of Medicine.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Okayama University, Department of Neurology, Graduate School of Medicine, Dentistry, and Pharmacological Sciences.
Fujita Health University, Department of Neurology.
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
東海大学医学部付属病院（神奈川県）
東海大学医学部付属八王子病院（東京都）
岡山大学病院（岡山県）
藤田保健衛生大学病院（愛知県）
富山大学病院（富山県）
山梨大学病院（山梨県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 25 | Day |
Last modified on
| 2015 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007818
