UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042800 |
|---|---|
| Receipt number | R000048864 |
| Scientific Title | Physician Awareness and Understanding of Hereditary Angioedema: A Web-based Study in Japan |
| Date of disclosure of the study information | 2020/12/28 |
| Last modified on | 2022/08/05 07:22:34 |
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Basic information
Public title
Physician Awareness and Understanding of Hereditary Angioedema: A Web-based Study in Japan
Acronym
HAE-JAPAN physician survey study
Scientific Title
Physician Awareness and Understanding of Hereditary Angioedema: A Web-based Study in Japan
Scientific Title:Acronym
HAE-JAPAN physician survey study
Region
| Japan |
Condition
Condition
Hereditary Angioedema
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Infectious disease | Geriatrics |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Pediatrics |
| Dermatology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the level of awareness of HAE and differential diagnoses among different physician specialties in Japan.
To determine the level of understanding of the flow of diagnosis in HAE.
To determine the factors for physicians to consider HAE in clinical setting.
Basic objectives2
Others
Basic objectives -Others
To measure how suspected or misdiagnosed HAE patients may be treated or followed up in Japan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
As this study is not intended for hypothesis testing, only descriptive analysis is shown and no endpoint is included in the study.
Key secondary outcomes
N/A
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Physicians registered to Nikkei BP panel and in active medical practice for > 1 year, are eligible for the study:
1.Internal medicine: General Physicians, Cardiology, Gastroenterology, Respirology, Nephrology, Hematology, Geriatrics, Endocrinology, Diabetology, Infectious Diseases, Neurology and Rheumatology
2.Dermatology
3.Pediatrics
4.Emergency medicine
5.Gastroenterological surgery
Key exclusion criteria
Have less than 1 year of practice excluding training period.
Currently participating or planning to participate in any clinical trials and receiving any investigational agents for HAE treatment.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | a)Atsushi b)Yoichi |
| Middle name | |
| Last name | a)Fukunaga b) Inoue |
Organization
a) Osaka Medical and Pharmaceutical University
b) Takeda Pharmaceutical Company Limited
Division name
a) Dermatology b) Japan Medical Office
Zip code
1.103-8668 2.650-0017
Address
a) a) 2-7 Daigakumachi, Takatsuki City, Osaka Prefecture 569-8686, Japan b) 1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
1.07049217478
1.yoichi.inoue@takeda.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kishimoto |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, 103-8668 Japan
TEL
08021719043
Homepage URL
miwa.kishimoto@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board.
Address
2F ST Shibuya bldg, 1-15-14, Dogenzaka, Shibuya-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
N/A
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/cia2.12265
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/cia2.12265
Number of participants that the trial has enrolled
692
Results
The proportions of physicians in dermatology, pediatrics, emergency medicine, internal medicine, and gastroenterological surgery who were able to select the C1-INH activity test as a diagnosis test for potential HAE patients were 71.8%, 59.7%, 57.1%, 40.3%, and 25.7%, respectively.
Results date posted
| 2022 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 29 | Day |
Baseline Characteristics
The following specialties: 238 in internal medicine, 110 in dermatology, 119 in pediatrics, 112 in emergency medicine, and 113 in gastroenterological surgery.
Participant flow
A web-based survey (Nikkei BP panel)
Adverse events
NA
Outcome measures
See Key Results section
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048864
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