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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005277
Receipt No. R000006272
Scientific Title Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Date of disclosure of the study information 2011/03/18
Last modified on 2012/03/19

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Basic information
Public title Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Acronym New therapeutic angiogenesis for peripheral artery disease
Scientific Title Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Scientific Title:Acronym New therapeutic angiogenesis for peripheral artery disease
Region
Japan

Condition
Condition Arteriosclerosis obliterans
Buerger's disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of Growth Factor (FGF) containing solution for the patients with PAD (ASO, Buerger's disease), who are unresponsive to standard therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Evaluation for Incidence, Severity, and Seriousness of adverse event
Key secondary outcomes Improvement of Fontaine and Rutherford Classification

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 Intramuscular injection of Growth Factor (FGF) containing solution
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with ASO or Buerger's disease
(2) Patient whose Fontaine classification is 3-4 and Rutherford classification is 4-6 in either limb.
(3) Patients with clinical improvement can not be obtained even after any existing medical and surgical treatment.
(4) Patient who can receive the protocol treatment for either limb.
(5) Patients who can give informed consent themselves in writing.
Key exclusion criteria (1) Patients with life expectancy likely to be within one year due to complications.
(2) Patients are scheduled for major lower limb amputation
(3) Patients with angina, congestive heart failure, or ventricular arrhythmia requiring treatment.
(4) Patients with myocardial infarction within three months.
(5) Left ventricular ejection fraction below 25%
(6) Patients with lower extremity revascularization within 3 months.
(7) Patient who performed percutaneous coronary intervention, bypass surgery within 1 month.
(8) Hemoglobin 7 g /dL or less
(9) Platelet count 70,000 / uL or less
(10) AST 100 IU or more, or ALT 100 IU or more
(11) Patients with malignant neoplasm requiring treatment.
(12) Patients with suspected infection and fever.
(13) Patients with uncontrolled diabetes over HbA1c 10%.
(14) Patients with diabetic proliferating retinopathy requiring treatment.
(15) Alprostadil Alfadex (for injection), Alprostadil (injection solution), Argatroban (injection solution), Trafermin (recombinant) in patients who are difficult to stop the worsening of symptoms could be stopped before surgery preparation.
(16) Patients with a history of severe drug allergy.
(17) Patients with negative skin reaction to decision not test solution.
(18) The females who are in pregnancy or lactation, may be pregnant, or are planning.
(19) Patients with a history of alcohol or drug dependence in past year.
(20) Patients who are considered unsuitable by other principal investigators.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Matsubara
Organization Department of Cardiovascular Medicine
Division name Kyoto Prefectural University of Medicine
Zip code
Address 465 Kajii-chyo,Kamigyo-ku, Kyoto
TEL 075-251-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoaki Matoba
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-chyo,Kamigyo-ku, Kyoto
TEL 075-251-5511
Homepage URL
Email

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 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
2011 Year 03 Month 18 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 No longer recruiting
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 18 Day
Last modified on
2012 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006272

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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