UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042800
Receipt No. 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 2021/04/12

* 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 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) Kobe University Graduate School of Medicine
b) Takeda Pharmaceutical Company Limited
Division name a) Division of Dermatology, Department of Internal Related b) Japan Medical Office
Zip code 1.103-8668 2.650-0017
Address a) 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan b) 1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL 1.07049217478
Email 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
Email miwa.kishimoto@takeda.com

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.