UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010754 |
|---|---|
| Receipt number | 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 10:37:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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
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
manyo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012021
