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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010754
Receipt No. R000012021
Scientific Title Pathophysiological study for autoimmune dysregulation of hereditary angioedema
Date of disclosure of the study information 2013/05/24
Last modified on 2017/11/21

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Basic information
Public title Pathophysiological study for autoimmune dysregulation of hereditary angioedema
Acronym Autoimmune dysregulation of hereditary angioedema
Scientific Title Pathophysiological study for autoimmune dysregulation of hereditary angioedema
Scientific Title:Acronym Autoimmune dysregulation of hereditary angioedema
Region
Japan

Condition
Condition Hereditary angioedema
Classification by specialty
Medicine in general Gastroenterology Clinical immunology
Gastrointestinal surgery Obsterics and gynecology Pediatrics
Dermatology Oto-rhino-laryngology Anesthesiology
Oral surgery Emergency medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the pathophysiological mechanisim of autoimune dysregulation in hereditary angioedema.
Basic objectives2 Others
Basic objectives -Others To detect autoantibody and to evaluate for opsonization and solubilization ability
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We plan to compare between the results and clinical backgrouds.
Key secondary outcomes We grope for the marker that reflect clinical severities.

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Blood collecting
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are diagnosed hereditary angioedema.
Key exclusion criteria nothing
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Mano
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, #113-8421, Japan
TEL 03-5802-1065
Email iohsawa@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Mano
Organization Complement group
Division name Division of Nephrology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, #113-8421, Japan
TEL 03-5802-1065
Homepage URL
Email manyo@juntendo.ac.jp

Sponsor
Institute Juntendo Hospital
Institute
Department

Funding Source
Organization Division of Nephrology,Department of Internal Medicine, Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor no
Name of secondary funder(s) no

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 順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/allergolint/63/4/63_14-OA-0700/_article
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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2017 Year 10 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
2013 Year 05 Month 17 Day
Last modified on
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012021

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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