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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036715
Receipt No. R000041835
Scientific Title blood sampling from the patients recovered from serious diseases(Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus)
Date of disclosure of the study information 2019/05/15
Last modified on 2019/05/11

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Basic information
Public title blood sampling from the patients recovered from serious diseases(Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus)
Acronym blood sampling from the patients recovered from serious diseases(Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus)
Scientific Title blood sampling from the patients recovered from serious diseases(Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus)
Scientific Title:Acronym blood sampling from the patients recovered from serious diseases(Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus)
Region
Japan

Condition
Condition Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus
Classification by specialty
Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To produce monoclonal antitoxin for Yamakagashi bites, Red back spider bites, diphtheria, gas gangrene, and botulinus
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes None
Key secondary outcomes

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
Vaccine
Interventions/Control_1 None
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
6 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients recovered from serious diseases
Key exclusion criteria Pregnant women
Infants
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Hifumi
Organization St. Luke's International Hospital
Division name Emergency Medicine
Zip code 104-8560
Address 9-1, Akashicho, Chuouku,Tokyo
TEL 03-3541-5151
Email hifumitoru@gmail.com

Public contact
Name of contact person
1st name Toru
Middle name
Last name Hifumi
Organization St. Luke's International Hospital
Division name Emergency Medicine
Zip code 104-8560
Address 9-1, Akashicho, Chuouku,Tokyo
TEL 03-3541-5151
Homepage URL
Email hifumitoru@gmail.com

Sponsor
Institute St. Luke's International Hospital
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Luke's International Hospital
Address 9-1, Akashicho, Chuouku,Tokyo
Tel 03-3541-5151
Email hifumitoru@gmail.com

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
2019 Year 05 Month 15 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 11 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041835

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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