UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathophysiological study for autoimmune dysregulation of hereditary angioedema
Title of the study (Brief title)	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	Satoshi Mano
Organization	Juntendo University Faculty of Medicine
Division name	Division of Nephrology, Department of Internal Medicine
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	Satoshi Mano
Organization	Complement group
Division name	Division of Nephrology
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

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	https://www.jstage.jst.go.jp/article/allergolint/63/4/63_14-OA-0700/_article
Results
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