UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042425 |
|---|---|
| Receipt number | 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 | 2024/09/12 07:00:13 |
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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
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
miwa.kishimoto@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
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
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
NA
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39258885/
Number of participants that the trial has enrolled
54
Results
All PROMs showed a substantial HRQoL impairment. Overall, the higher the attack frequencies, the greater the impairment in the PROMs tended to be reported. In multiple linear regression analyses, higher AE-QoL Fatigue/Mood and Fears/Shame domain scores were associated with higher HADS anxiety subscale scores; higher AE-QoL total scores and lower SF-12 Physical and Mental Health Composite scores were associated with higher HADS depression subscale scores.
Results date posted
| 2024 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
NA
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 11 | Day |
Baseline Characteristics
Male:7, Female: 47
HAE type I and II: 44
HAE type III: 5
Unknown: 5
Participant flow
Study participants were recruited from February 2021 to June 2021 through two HAE patient advocacy groups in Japan: Hereditary Angioedema Japan (HAEJ),43 a registered non-profit patient organization, and Kumi-mu.
Adverse events
NA
Outcome measures
Patient reported outcomes using SF-12, AE-QoL, HADS, WPAI and PROM
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 06 | 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
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048140
