UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054086 |
|---|---|
| Receipt number | R000061727 |
| Scientific Title | The humanistic burden of hereditary angioedema (HAE): a patient survey in Japan |
| Date of disclosure of the study information | 2024/04/09 |
| Last modified on | 2024/04/04 17:42:54 |
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Basic information
Public title
A survey study of HAE patients: mental QoL and treatment preferences
Acronym
A survey study of HAE patients: mental QoL and treatment preferences
Scientific Title
The humanistic burden of hereditary angioedema (HAE): a patient survey in Japan
Scientific Title:Acronym
The humanistic burden of hereditary angioedema (HAE): a patient survey in Japan
Region
| Japan |
Condition
Condition
Hereditary angioedema: HAE
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact and degree that HAE affects anxiety and depression as well as angioedema-related Quality of Life (QoL) in Japanese HAE patients
Basic objectives2
Others
Basic objectives -Others
HADS, AE-QoL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The impact and degree that HAE affects anxiety and depression as well as angioedema-related quality of life (QoL) in Japanese HAE patients: HADS, AE-QoL
Key secondary outcomes
1)The treatment satisfaction in Japanese HAE patients:TSQM-9
2)The impact of HAE on the work productivity and generic health status in Japanese HAE patients:EQ-5D-5L,WPAI-GH
3)Patients' most important factor for deciding medication preference for HAE in Japanese patients
4)The impacts of the demographics, clinical and disease characteristics on HADS in Japanese HAE patients
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
Participants must meet all of the following inclusion criteria:
1)Female or male aged >= 12 years, as the date of responding to the survey
2)Self-reported to have been diagnosed with HAE by a physician
3)Able to provide informed consent to participate in the study and willing to participate in the study
Key exclusion criteria
Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
1)Participants who are not members of either the HAEJ or CREATE patient groups
2)Participants who have already responded to this study via the other patient group
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Terasaka |
Organization
CSL Behring K.K.
Division name
Medical Affairs
Zip code
107-0061
Address
1-2-3 Kita-aoyama, Minato-ku, Tokyo 107-0061, Japan
TEL
070-8702-1080
Naoki.Terasaka@cslbehring.com
Public contact
Name of contact person
| 1st name | Michael |
| Middle name | |
| Last name | LOPRESTI |
Organization
INTAGE Healthcare Inc
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
050-3640-1444
Homepage URL
m.lopresti@intage.com
Sponsor or person
Institute
CSL Behring K.K
Institute
Department
Personal name
Funding Source
Organization
CSL Behring K.K.
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 09 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment method: Participants will be recruited through survey participation requests via email to patients from two HAE patient advocacy groups in Japan.
Management information
Registered date
| 2024 | Year | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061727
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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