UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050129 |
|---|---|
| Receipt number | R000056725 |
| Scientific Title | Digital Biomarkers Study in Patients with Hereditary Angioedema in Japan: Exploratory Longitudinal Study about Trigger Factors of HAE Attacks |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2024/03/18 08:40:13 |
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Basic information
Public title
Digital Biomarkers Study in Patients with Hereditary Angioedema in Japan: Exploratory Longitudinal Study about Trigger Factors of HAE Attacks
Acronym
HAE digital biomarker study
Scientific Title
Digital Biomarkers Study in Patients with Hereditary Angioedema in Japan: Exploratory Longitudinal Study about Trigger Factors of HAE Attacks
Scientific Title:Acronym
HAE digital biomarker study
Region
| Japan |
Condition
Condition
Hereditary Angioedema (HAE)
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Nephrology |
| Clinical immunology | Dermatology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective
To explore digital biomarkers in real-world settings that are correlated to HAE attacks which may become potential attack predictors
Secondary objective
To examine the relationship between medium- to long- term stress levels and the occurrence of HAE attacks
Basic objectives2
Others
Basic objectives -Others
the relationship between HAE attacks and various data
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-Differences in data from various biological data from a wearable device within 48 hours prior to HAE attack and for 48 hours without HAE attack
-Correlation coefficients between HAE attack frequency and various data from a wearable device
Key secondary outcomes
-To examine the occurrence of attacks and associated behaviors
-To develop prediction models and investigate the factors that trigger attacks
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who were diagnosed as HAE (Type 1, Type 2, HAE-nC1-INH )
(40 subjects of type 1 or 2, and at most 10 subjects of HAE-nC1-INH)
2.Patients who have experienced two or more attacks of HAE in the past half year from the time of consent
3.Patients aged 12 years or older when providing informed consent
4.Patients judged by the principal investigator or subinvestigator to understand and comply with the study, and to be able to operate the devices
5.Patients who can sign and date the informed consent form by themselves or, if applicable, legally acceptable representatives of the patients prior to the study procedure
Key exclusion criteria
1.Patients who have severe complications (e.g., uncontrolled hypertension, diabetes mellitus, heart failure, etc.) and judged to have difficulty performing normal daily physical activities
2.Patients who have difficulty wearing wearable devices used in this study on a daily basis
3.Patients who are considered ineligible for this study for other reasons by the principal investigator or subinvestigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hosono |
| Middle name | |
| Last name | Kumiko |
Organization
Takeda Pharmaceutical Company Limited
Division name
Medical Franchise Rare Disease Scientific director / Japan Medical Office
Zip code
103-8668
Address
2-1-1 Nihonbashi Honcho, Chuo-ku, Tokyo
TEL
03-3278-2111
gen.suzuki@takeda.com
Public contact
Name of contact person
| 1st name | Suzuki |
| Middle name | |
| Last name | Yuta |
Organization
Mebix, Inc.
Division name
Division of research promotion
Zip code
107-0052
Address
Akasaka Intercity 1-11-44 Akasaka, Minato-ku, Tokyo
TEL
03-4362-4504
Homepage URL
HAEeCOA_cra@mebix.co.jp
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
takahashi clinic ethics committee
Address
5-1-31 Iwaya Kita-machi, Nada-ku, Kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.jp
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
1. 昭和大学病院 (東京都)
2. 広島市立広島市民病院 (広島県)
3. 健和会大手町病院 (福岡県)
4.（欠番）
5. 順天堂大学医学部附属順天堂医院 (東京都)
6. 浜松医科大学医学部附属病院 (静岡県)
7. 新潟市民病院 (新潟県)
8. 広島大学病院 (広島県)
9. 埼友草加病院 (埼玉県)
10. 奈良県立医科大学附属病院 (奈良県)
11. 札幌医科大学附属病院 (北海道)
12. 北海道医療大学病院 (北海道)
13. マツダ病院 (広島県)
14. 山形大学医学部附属病院 (山形県)
15.（欠番）
16．大阪大学医学部附属病院（大阪府）
17．市立千歳市民病院（北海道）
18．総合病院 国保旭中央病院（千葉県）
19. 大阪市立総合医療センター（大阪府）
20. 済生会熊本病院（熊本県）
21. 千葉大学医学部附属病院（千葉県）
22. （欠番）
23. クローバーホスピタル（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 31 | 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
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
-This is a multi-centered, prospective, observational study.
-Wearable devices will be used during 48-week observation period, and biological information and activity information (wearable device data) will be obtained automatically and continuously from subjects.
-Visit surveys will be conducted every 8 weeks. At Week 4, a non-mandatory visit observation will be scheduled.
Management information
Registered date
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056725
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| Registered date | File name |
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