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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042425
Receipt No. R000048140
Scientific Title Quantifying the burden of disease and perceived health state in patients with Hereditary Angioedema in Japan: Patient-Reported Outcomes study
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/12

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Basic information
Public title Quantifying the burden of disease and perceived health state in patients with Hereditary Angioedema in Japan: Patient-Reported Outcomes study
Acronym HAE-PRO study
Scientific Title Quantifying the burden of disease and perceived health state in patients with Hereditary Angioedema in Japan: Patient-Reported Outcomes study
Scientific Title:Acronym HAE-PRO study
Region
Japan

Condition
Condition Hereditary Angioedema
Classification by specialty
Clinical immunology Dermatology Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the health-related quality of life of Japanese patients with HAE using AE-QOL
Basic objectives2 Others
Basic objectives -Others QOL
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To assess the health-related quality of life of Japanese patients with HAE using AE-QOL
Key secondary outcomes 1) To assess disease activity and mental health using AAS and HADS

2) To assess general health status and work productivity using SF-12 and WPAI

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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The subject has been diagnosed with HAE by a physician and is 18 years or older in age
Key exclusion criteria Currently participating or planning to participate in any clinical trials and receiving any investigational agents for HAE treatment.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name (1) Michihiro, (2) Yoichi
Middle name
Last name (1) Hide, (2) Inoue
Organization (1) Graduate School of Biomedical and Health Sciences, Hiroshima University
(2)Takeda Pharmaceutical Company Limited
Division name (1) Department of Dermatology, (2)Japan Medical Office
Zip code (1)734-8551(2)103-8668
Address (1) 1-2-3, Minami-ku hiroshima-shi, (2)1-1, Nihonbashi-Honcho 2-chome, Chuo-ku,
TEL (1)082-257-5235(2)070-4921-7478
Email 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, Japan
TEL 080-2171-9043
Homepage URL
Email miwa.kishimoto@takeda.com

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Non-Profit Organization MINS Institutional Review Board
Address ST Shibuya Building 2F, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo
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 なし

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 02 Day
Last follow-up date
2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048140

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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